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P.F.C. Sigma 1581-96-633

by Depuy Orthopaedics, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

31 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 Number10603295065128 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

31 recalls · FDA

    • Terminated Z-1077-2014 FDA Class II initiated 9 Dec 2013

    Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.

    • Terminated Z-1686-2009 FDA Unclassified (pre-2012) initiated 7 May 2009

    There may be a crack on the lateral side of the condyle in the posterior chamfer region. The device is used as a Orthopedic knee implant.

  • 28 recalls, same reason

    • Terminated Z-0418-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0406-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0394-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0385-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0392-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0404-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0386-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0405-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0391-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0421-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0422-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0403-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0388-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0395-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0387-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0420-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0419-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0407-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0393-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0402-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K943462
    • Terminated Z-0389-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-0390-2008 FDA Unclassified (pre-2012) initiated 27 Sep 2007 on shared 510(k) K950010
    • Terminated Z-1319-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1315-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1316-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1318-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1320-05 FDA Unclassified (pre-2012) initiated 26 May 2005
    • Terminated Z-1317-05 FDA Unclassified (pre-2012) initiated 26 May 2005

    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-0057-2007 FDA Unclassified (pre-2012) initiated 14 Sep 2006

    Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.

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
Uncoated knee tibia prosthesis, polyethylene
Model / Ref / Catalog
1581-96-633, 158196633
Primary DI / UDI-DI
10603295065128
510(k) Number
FDA Product Code
JWH
GMDN Term
Uncoated knee tibia prosthesis, polyethylene
Device Class
Class II
Regulation Number
888.3560
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Uncoated knee tibia prosthesis, polyethylene

Cleared under the same submission (K943462)

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Cleared under the same submission (K950010)

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Cleared under the same submission (K961685)

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Cleared under the same submission (K971189)

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Other devices from Depuy Orthopaedics, Inc.

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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