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6728-94

by Zimmer, Inc.

6728-94 (00-6728-094-00) is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K921308 on 22 Feb 1994 (1 earlier submission) and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 00889024408586), active as of 22 Oct 2026. 8 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

9 closed

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00889024408586 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK921308 Date22 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K921308 decided 22 Feb 1994 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00889024408586 listed 16 Oct 2015 Listed

Recalls

9 recalls · FDA

    • Terminated Z-1683-2016 FDA Class II initiated 4 May 2016

    A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

  • 4 recalls, same reason

    • Terminated Z-1137-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1131-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1110-2016 FDA Class II initiated 11 Jan 2016
    • Terminated Z-1126-2016 FDA Class II initiated 11 Jan 2016

    As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

  • 4 recalls, same reason

    • Terminated Z-1026-2014 FDA Class II initiated 11 Oct 2013 on shared 510(k) K921308
    • Terminated Z-1025-2014 FDA Class II initiated 11 Oct 2013
    • Terminated Z-1033-2014 FDA Class II initiated 11 Oct 2013
    • Terminated Z-1036-2014 FDA Class II initiated 11 Oct 2013

    Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

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

Timeline

12 dated events

  1. Recall initiated FDA recalls Z-1026-2014
  2. Recall initiated FDA recalls Z-1025-2014
  3. Recall initiated FDA recalls Z-1033-2014
  4. Recall initiated FDA recalls Z-1036-2014
  5. Listed FDA GUDID 00889024408586
  6. Recall initiated FDA recalls Z-1137-2016
  7. Recall initiated FDA recalls Z-1131-2016
  8. Recall initiated FDA recalls Z-1110-2016
  9. Recall initiated FDA recalls Z-1126-2016
  10. Recall initiated FDA recalls Z-1683-2016

2 earlier events are in the sections above.

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Non-constrained polyethylene acetabular liner
Model / Ref / Catalog
6728-94, 00-6728-094-00
Primary DI / UDI-DI
00889024408586
510(k) Number
FDA product code
JDI
GMDN term
Non-constrained polyethylene acetabular liner
Device class
Class II
Regulation number
888.3350
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 28 Millimeter

Related devices

Category: Non-constrained polyethylene acetabular liner

Cleared under the same submission (K840643)

and 8 more cleared under K840643

Cleared under the same submission (K921308)

and 8 more cleared under K921308

Similar devices in this category

Other devices filed under Non-constrained polyethylene acetabular liner.

Other devices from Zimmer, Inc.

See all devices from Zimmer, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)