6728-95

• FDA 510(k) K840643 decided 17 Apr 1984 Active
• FDA GUDID UDI-DI 00889024408593 listed 16 Oct 2015 Listed

• • 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.

• 3 recalls, same reason

  • 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.

1. 17 Apr 1984 Cleared FDA 510(k) K840643
2. 11 Oct 2013 Recall initiated FDA recalls Z-1025-2014
3. 11 Oct 2013 Recall initiated FDA recalls Z-1033-2014
4. 11 Oct 2013 Recall initiated FDA recalls Z-1036-2014
5. 16 Oct 2015 Listed FDA GUDID 00889024408593
6. 11 Jan 2016 Recall initiated FDA recalls Z-1137-2016
7. 11 Jan 2016 Recall initiated FDA recalls Z-1131-2016
8. 11 Jan 2016 Recall initiated FDA recalls Z-1110-2016
9. 11 Jan 2016 Recall initiated FDA recalls Z-1126-2016
10. 4 May 2016 Recall initiated FDA recalls Z-1683-2016

Generic name

Non-constrained polyethylene acetabular liner

Model / Ref / Catalog

6728-95, 00-6728-095-00

Primary DI / UDI-DI

00889024408593

510(k) Number

K840643 ↗

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

Category: Non-constrained polyethylene acetabular liner

Other devices filed under Non-constrained polyethylene acetabular liner.

• Cross-Linked PE Insert Acetabular Insert 0884004 by ADLER ORTHO SPA
• Trinity Acetabular Hip System with HXLPE Liners 321.04.928 by CORIN LTD
• U2 Acetabular Components 1403-1358 by UNITED ORTHOPEDIC CORP.
• U2 Acetabular Components 1403-5460 by UNITED ORTHOPEDIC CORP.
• MobiliT Cup HDM2854 by CORIN LTD
• Elevated Acetabular Liner P28023258 by Tianjin Zhengtian Medical Instrument Co., Ltd.
• Pyramid Hip Insert 332012 by Atesos medical AG
• ORTOPRO 28.2831 by ORTOPRO TIB. ALETLER SAN. VE TİC. A.Ş. ESB ŞUBESİ

• OsseoFit 00-5381-008-05

  Class I

  GUDID on market

• OsseoFit 00-5381-013-00

  Class I

  GUDID on market

• OsseoFit 00-5381-008-06

  Class I

  GUDID on market

• OsseoFit 00-5381-013-11

  Class I

  GUDID on market

See all devices from Zimmer, Inc. →