6722-95
by Zimmer, Inc.
6722-95 (00-6722-095-00) is a Class II device made by Zimmer, Inc., cleared under FDA 510(k) K840643 on 17 Apr 1984 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 00889024408364), active as of 22 Oct 2026. 8 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889024408364 | Date16 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK840643 | Date17 Apr 1984 | StatusActive |
Official records
- AccessGUDID record 00889024408364
- FDA 510(k) database K840643
Across registries
- FDA 510(k) K840643 decided 17 Apr 1984 Active
- FDA GUDID UDI-DI 00889024408364 listed 16 Oct 2015 Listed
Recalls
-
- Terminated Z-1683-2016
A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
-
- Terminated Z-1137-2016
- Terminated Z-1131-2016
- Terminated Z-1110-2016
- Terminated Z-1126-2016
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.
-
- Terminated Z-1025-2014
- Terminated Z-1033-2014
- Terminated Z-1036-2014
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.
Timeline
- Cleared FDA 510(k) K840643
- Recall initiated FDA recalls Z-1025-2014
- Recall initiated FDA recalls Z-1033-2014
- Recall initiated FDA recalls Z-1036-2014
- Listed FDA GUDID 00889024408364
- Recall initiated FDA recalls Z-1137-2016
- Recall initiated FDA recalls Z-1131-2016
- Recall initiated FDA recalls Z-1110-2016
- Recall initiated FDA recalls Z-1126-2016
- Recall initiated FDA recalls Z-1683-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Non-constrained polyethylene acetabular liner
- Model / Ref / Catalog
- 6722-95, 00-6722-095-00
- Primary DI / UDI-DI
- 00889024408364
- 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 — 22 Millimeter
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