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P.F.C. Sigma 96-0552

by Depuy (Ireland)

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

8 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10603295233305 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

8 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 on shared 510(k) K952830
    • Terminated Z-0399-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0397-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0398-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0396-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830
    • Terminated Z-0400-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K952830

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

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
P.F.C. Sigma
Generic Name
Tibial insert
Model / Ref / Catalog
96-0552, 960552
Primary DI / UDI-DI
10603295233305
510(k) Number
FDA Product Code
JWH
GMDN Term
Tibial insert
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Tibial insert

Cleared under the same submission (K241000)

Show all (12)

Cleared under the same submission (K952830)

Show all (12)

Other devices from Depuy (Ireland)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No