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Synthes (USA) Products LLC

Country not established FDA establishment FEI 3008812560

Devices
61
Registrations
FDA
FDA recalls
16424 ongoing

Catalogue61

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Company details

FDA FEI number
3008812560
Address
1301 Goshen Pkwy, West Chester, PA, 19380

FDA recalls164

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 9
  • 2018 7
  • 2019 2
  • 2020 33
  • 2021 1
  • 2022 6
  • 2023 3
  • 2024 10
  • 2025 2
  • 2026 2

89 initiated before 2017

Showing the 10 most recent of 164 recalls.

  • 2026

    • 25 Feb 2026 Z-1702-2026 Class II Ongoing A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA,…
      Full distribution text US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.
    • 25 Feb 2026 Z-1703-2026 Class II Ongoing A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. Distribution: US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA,…
      Full distribution text US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD, MN, NC, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI.

  • 2025

    • 26 Sep 2025 Z-0228-2026 Class II Ongoing Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO,…
      Full distribution text Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.
      Submission numbers: K201336, K201346
    • 26 Sep 2025 Z-0229-2026 Class II Ongoing Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. Distribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO,…
      Full distribution text Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.
      Submission numbers: K201336, K201346

  • 2024

    • 25 Apr 2024 Z-1916-2024 Class II Ongoing Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay Distribution: Worldwide distribution - US Nationwide and the country of Canada.
    • 24 Jan 2024 Z-1234-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
      Submission number: K051678
    • 24 Jan 2024 Z-1235-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
    • 24 Jan 2024 Z-1236-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
    • 24 Jan 2024 Z-1237-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
      Submission numbers: K042899, K111437, K013527
    • 24 Jan 2024 Z-1238-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
      Submission number: K141385
Show the 25 most recent of 164 recalls

  • 2024

    • 24 Jan 2024 Z-1239-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
      Submission numbers: K131548, K160167
    • 24 Jan 2024 Z-1240-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
      Submission numbers: K131548, K160167
    • 24 Jan 2024 Z-1241-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.
      Submission number: K201321
    • 24 Jan 2024 Z-1242-2024 Class II Ongoing Products not sterilized, sterility cannot be confirmed Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Argentina, Austria, Australia, Belgium, Canada, Czech Republic, Germany, Spain, Finland, France, United Kingdom, Ireland, South Korea, Kuwait, Mexico, Netherlands, Slovakia, Taiwan, South Africa.

  • 2023

    • 1 Feb 2023 Z-1246-2023 Class II Ongoing TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Distribution: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan. Submission number: K131548
    • 1 Feb 2023 Z-1247-2023 Class II Ongoing TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Distribution: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan. Submission number: K131548
    • 1 Feb 2023 Z-1248-2023 Class II Ongoing TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length Distribution: Worldwide - US Nationwide distribution in the states of MS, OR, TX and the countries of Canada, Japan. Submission number: K131548

  • 2022

    • 27 Sep 2022 Z-0098-2023 Class II Ongoing The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. Distribution: US Nationwide distribution. Submission number: K142292
    • 27 Sep 2022 Z-0099-2023 Class II Ongoing The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. Distribution: US Nationwide distribution. Submission number: K142292
    • 27 Sep 2022 Z-0100-2023 Class II Ongoing The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. Distribution: US Nationwide distribution. Submission number: K142292
    • 27 Sep 2022 Z-0101-2023 Class II Ongoing The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit. Distribution: US Nationwide distribution. Submission number: K191463
    • 30 Aug 2022 Z-0008-2023 Class II Ongoing Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate an alternative form of fixation. Additionally, there is a potential for adverse tissue reaction if the surgeon attempts to use the guide regardless of tight fit and plastic debris is created and ends up in the wound Distribution: US Nationwide distribution. Submission number: K191463
    • 7 Apr 2022 Z-1072-2022 Class II Ongoing DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis. Distribution: US Nationwide distribution. Submission number: K183618

  • 2021

    • 22 Dec 2021 Z-0634-2022 Class II Ongoing Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection. Distribution: US Nationwide distribution.

  • 2020

    • 19 Nov 2020 Z-0571-2021 Class II Terminated RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed Distribution: Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic,…
      Full distribution text Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore,
      Submission numbers: K042899, K111437, K013527, K993335

Frequently asked questions

How many devices does Synthes (USA) Products LLC have in the registry?

The registry currently lists 61 devices for Synthes (USA) Products LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list Synthes (USA) Products LLC's devices?

Among its 50 most recently registered devices, Synthes (USA) Products LLC has devices listed in FDA 510(k) (50 devices).

What risk classes do Synthes (USA) Products LLC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Synthes (USA) Products LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Synthes (USA) Products LLC?

FDA recall records list 164 recalls initiated by Synthes (USA) Products LLC, the most recent initiated on 2026-02-25. 24 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Synthes (USA) Products LLC in the registry?

The most recently registered devices listed for Synthes (USA) Products LLC include MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction System, DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM, USS System and MATRIXRIB FIXATION SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.