Home / Recalls / Biomet U.K., Ltd. / Z-1170-2017

Z-1170-2017 Class II Terminated

Recalled by Biomet U.K., Ltd. — Bridgend South Wales, N/A

FDA device recall Z-1170-2017 was initiated by Biomet U.K., Ltd. on January 5, 2016 and is designated Class II. Reason for recall: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected pr… The recall status is terminated (terminated June 30, 2018). Affected quantity: 72 units in total.

Recall Details

Product Type
Devices
Report Date
March 1, 2017
Initiation Date
January 5, 2016
Termination Date
June 30, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
72 units in total

Product Description

Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Reason for Recall

Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.

Distribution Pattern

Worldwide Distribution in the states of LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ and the countries of Foreign: THAILAND, JAPAN, NETHERLANDS

Code Information

Item:32-420663, Lots: ZB160601, ZB160701

Other recalls by Biomet U.K., Ltd.

  • Z-1166-2017 Class II — Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: (January 5, 2016)
  • Z-1153-2017 Class II — Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for (January 5, 2016)
  • Z-1168-2017 Class II — Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments fo (January 5, 2016)
  • Z-1162-2017 Class II — Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: (January 5, 2016)
  • Z-1152-2017 Class II — Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instrum (January 5, 2016)
  • Z-1167-2017 Class II — Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: (January 5, 2016)
  • Z-1165-2017 Class II — Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Part (January 5, 2016)
  • Z-1173-2017 Class II — Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product (January 5, 2016)
  • Z-1158-2017 Class II — Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: (January 5, 2016)
  • Z-1159-2017 Class II — Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage (January 5, 2016)

FDA data resources