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CPT DEGREE TAPER (various sizes) and FEMORAL HD (various… recallZ-1036-2014 · Zimmer, Inc. · initiated Oct 11, 2013

Class II Terminated All recalls posted in February 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Packaging

What the company is doing

Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.

Recall details

Recall number
Z-1036-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 11, 2013
Posted by the FDA
Feb 20, 2014
Recalling firm
Zimmer, Inc.
Quantity
7,044,680 total
Product code
JDI
FDA submissions
K840643, K960658
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.

Product description

CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)

Code information (models, lots, serial numbers)

60275282 60089260 60145841 60147718 60156456 60089259 60156459 60200116 62135079 62079190 60732916 60638837 62094973 61887194 60457227

Other devices under the same FDA submission

40 devices cleared under K840643, K960658 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 66500).

Sources and updates

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