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Wedges

by DePuy Ireland UC Ireland EUDAMEDGUDID

Ref 86-0379Model PFC Sigma Wedges

Product code JWHEMDN P09098001

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a004418Q Basic UDI-DIDate4 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295216063 UDI-DIDate24 Sep 2015ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

9 recalls · FDA

    • Terminated Z-2949-2018 FDA Class II initiated 18 Jul 2018

    This unit may be missing the screw/collet Assembly

  • 6 recalls, same reason

    • Terminated Z-0401-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K952830, on the same 510(k)
    • Terminated Z-0399-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K952830, on the same 510(k)
    • Terminated Z-0397-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K952830, on the same 510(k)
    • Terminated Z-0398-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K952830, on the same 510(k)
    • Terminated Z-0400-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K952830, on the same 510(k)
    • Terminated Z-0396-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 via K952830, on the same 510(k)

    An incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.

    • Terminated Z-1382-04 FDA Unclassified (pre-2012) initiated 15 Jan 2004

    Screw size included in system was incorrect

    • Terminated Z-1369-04 FDA Unclassified (pre-2012) initiated 22 Dec 2003

    The collar was incorrectly etched for the R (right) and L (Left) orientation

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
P.F.C.
Generic Name
Knee arthroplasty wedge
Device Name
Wedges
Model / Ref / Catalog
PFC Sigma Wedges, 86-0379, 860379
Primary DI / UDI-DI
10603295216063
Basic UDI-DI
0603295a004418Q
510(k) Number
FDA Product Code
JWH
EMDN Code
P09098001 Knee prostheses augments
GMDN Term
Knee arthroplasty wedge
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3560
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (17)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED dbeb0129-7e96-4d0d-bc4f-035d42e22ef2 61 fields · synced 22 Oct 2026
  • FDA UDI aea312d7-1a6d-4d26-be91-4af7dbf28b80 36 fields · synced 30 May 2026