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Smith & Nephew, Inc.

Last updated September 17, 2026

Information

Country: US
Address: 7135 Goodlett Farms Pkwy, Cordova, TN, 38016
Website: smith-nephew.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)238-7538
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3008744062
DUNS Number: 045483575

Catalogue (48998)

Page 1 of 500

Device	Model / Reference	Registries	Class	Status
Surgical Instruments	CSA-1001-01	FDA UDI	Class I	Active
Ti6 Internal Fixation System	TC4024	FDA UDI	Class II	Active
R3	E0016709-7	FDA UDI	Class I	Active
Smart Tsf	71074550	FDA UDI	Class II	Active
R3	E0015364-4	FDA UDI	Class II	Active
R3	71337554	FDA UDI	Class II	Active
Genesis Ii	71440852	FDA UDI	Class II	Active
Emperion	71291573	FDA UDI	Class II	Unknown
Titan Modular Shoulder System 2.5	RMR-0926-02N	FDA UDI	Class I	Active
Legion	E0016953-3	FDA UDI	Class I	Active
Trigen	71935600	FDA UDI	Class I	Active
Evos	72467409N	FDA UDI	Class II	Active
D-Rad	71158024	FDA UDI	Class II	Active
Peri-Loc	71860806	FDA UDI	Class II	Active
Redapt	71354036	FDA UDI	Class II	Active
Peri-Loc	71807024	FDA UDI	Class II	Active
Acufex	7207201	FDA UDI	Class I	Active
Other External Fixation	71112742	FDA UDI	Class II	Active
Stride	PFSI00033	FDA UDI	Class II	Active
Profix	71512110	FDA UDI	Class II	Unknown
Polarstem	75004650	FDA UDI	Class I	Active
No Brand	72205422	FDA UDI	Class I	Active
Real Intelligence	ROB10074	FDA UDI	Class II	Active
Journey II	E0017925-8	FDA UDI	Class II	Active
Journey	E0016791-2	FDA UDI	Class II	Active
Smart Tsf	71074525	FDA UDI	Class II	Active
Jii	E0016342-15	FDA UDI	Class II	Active
Ex-Fix	E0015408-2	FDA UDI	Class II	Active
Journey Ii Uni	74036041	FDA UDI	Class II	Active
Journey	74026194	FDA UDI	Class II	Active
Profix	71517134	FDA UDI	Class I	Active
Genesis Ii	71440014	FDA UDI	Class II	Active
Genesis Ii	71420062	FDA UDI	Class II	Active
Evos	72556535	FDA UDI	Class II	Active
Legion	E0017737-2	FDA UDI	Class II	Active
Legion	E0016941-3	FDA UDI	Class II	Active
Redapt	71355374	FDA UDI	Class I	Active
Legion	E0014906-8	FDA UDI	Class II	Unknown
Endo - Knee	E0016307-6	FDA UDI	Class I	Active
Journey II	E0015320-1	FDA UDI	Class II	Active
Trigen	E0014945-1	FDA UDI	Class I	Active
Meta-nail	E0014955-1	FDA UDI	Class I	Unknown
Vlp Mini-Mod	71173896	FDA UDI	Class I	Active
TC-PLUS Primary	75000370	FDA UDI	Class II	Active
Promos	75003699	FDA UDI	Class II	Active
Zuk	00584102310	FDA UDI	Class I	Active
Biorci	7209012	FDA UDI	Class II	Active
Modular Rail System	71933343	FDA UDI	Class II	Active
Peri-Loc	71865280	FDA UDI	Class II	Active
Healicoil / Ultrabraid	72203707	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Nov 24, 2025	Z-0957-2026	—	open, classified	Removal of affected lot of screws due to labeling error.
Mar 18, 2025	Z-1806-2025	—	open, classified	Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Oct 29, 2024	Z-0581-2025	—	open, classified	Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Oct 15, 2024	Z-0326-2025	—	open, classified	The Bipolar assembly contains an oversized Retainer Ring.
Oct 2, 2024	Z-0278-2025	—	open, classified	Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Oct 2, 2024	Z-0281-2025	—	open, classified	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Oct 2, 2024	Z-0277-2025	—	open, classified	Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Oct 2, 2024	Z-0282-2025	—	open, classified	Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Aug 12, 2024	Z-3096-2024	—	open, classified	Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Aug 12, 2024	Z-3097-2024	—	open, classified	Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Jul 9, 2024	Z-3171-2024	—	open, classified	Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
Jul 9, 2024	Z-3172-2024	—	open, classified	Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
Apr 24, 2024	Z-1901-2024	—	open, classified	Packaging contained the incorrect size of femoral head from what was displayed on the label.
Sep 27, 2023	Z-0158-2024	—	open, classified	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Sep 27, 2023	Z-0157-2024	—	open, classified	The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Aug 31, 2023	Z-2621-2023	—	open, classified	The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
Jul 24, 2023	Z-2443-2023	—	open, classified	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
Jul 24, 2023	Z-2444-2023	—	open, classified	A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
May 2, 2023	Z-1670-2023	—	open, classified	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
May 2, 2023	Z-1672-2023	—	open, classified	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
May 2, 2023	Z-1673-2023	—	open, classified	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
May 2, 2023	Z-1671-2023	—	open, classified	Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
Mar 27, 2023	Z-1393-2023	—	open, classified	A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
Jun 27, 2022	Z-1418-2022	—	terminated	The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
Apr 19, 2022	Z-1099-2022	—	terminated	It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
Jan 4, 2022	Z-0548-2022	—	open, classified	The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
Dec 14, 2021	Z-0635-2022	—	open, classified	Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Nov 1, 2021	Z-0365-2022	—	open, classified	Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Nov 1, 2021	Z-0363-2022	—	open, classified	Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Nov 1, 2021	Z-0364-2022	—	open, classified	Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Nov 1, 2021	Z-0366-2022	—	open, classified	Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Oct 25, 2021	Z-0265-2022	—	open, classified	The labels on the packages of screws were switched.
Sep 20, 2021	Z-0143-2022	—	terminated	The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
May 19, 2021	Z-1951-2021	—	terminated	The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Apr 8, 2021	Z-1510-2021	—	terminated	Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
Dec 18, 2020	Z-0933-2021	—	terminated	Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
Nov 2, 2020	Z-0772-2021	—	terminated	Manufacturing packaging error.
Sep 21, 2020	Z-0118-2021	—	open, classified	The anterior locking detail does not meet its design specifications.
Sep 21, 2020	Z-0301-2021	—	terminated	The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
Sep 9, 2020	Z-0165-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0170-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0174-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0142-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0143-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0157-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0141-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0148-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0138-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0151-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0146-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0167-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0147-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0145-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0163-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0160-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0158-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0140-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0136-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0156-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0149-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0137-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0153-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0159-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0173-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0139-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0171-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0154-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0164-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0152-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0172-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0144-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0168-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0155-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0161-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0150-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0162-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0166-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0175-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Sep 9, 2020	Z-0169-2021	—	open, classified	Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Aug 24, 2020	Z-2945-2020	—	terminated	Multiple or incorrect expiration dates were provided on the affected designation labels.
Aug 3, 2020	Z-2818-2020	—	open, classified	The products were improperly heat treated.
Jul 16, 2020	Z-2774-2020	—	open, classified	Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
Jun 29, 2020	Z-2777-2020	—	terminated	The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
Jun 24, 2020	Z-2702-2020	—	open, classified	The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
Jun 24, 2020	Z-2746-2020	—	open, classified	A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
Jun 24, 2020	Z-2685-2020	—	terminated	A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Apr 22, 2020	Z-2331-2020	—	open, classified	A manufacturing error resulted in out of specification R3 Acetabular Shells
Apr 22, 2020	Z-2334-2020	—	open, classified	A manufacturing error resulted in out of specification R3 Acetabular Shells
Apr 22, 2020	Z-2333-2020	—	open, classified	A manufacturing error resulted in out of specification R3 Acetabular Shells
Apr 22, 2020	Z-2332-2020	—	open, classified	A manufacturing error resulted in out of specification R3 Acetabular Shells
Apr 22, 2020	Z-2335-2020	—	open, classified	A manufacturing error resulted in out of specification R3 Acetabular Shells
Apr 22, 2020	Z-2336-2020	—	open, classified	A manufacturing error resulted in out of specification R3 Acetabular Shells
Mar 17, 2020	Z-1756-2020	—	open, classified	Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.
Mar 17, 2020	Z-1757-2020	—	open, classified	Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchor s tip protector allowing the tip of the anchor to create a sterile breach.
Feb 27, 2020	Z-1634-2020	—	terminated	Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
Jan 28, 2020	Z-2132-2020	—	terminated	The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
Jan 28, 2020	Z-2133-2020	—	terminated	The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
Dec 30, 2019	Z-1273-2020	—	terminated	Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.
Dec 19, 2019	Z-1507-2020	—	terminated	LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Dec 16, 2019	Z-0878-2020	—	open, classified	Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Smith & Nephew Inc. OKLAHOMA CITY, OK · US FEI 1643264