Home / Recalls / Zimmer, Inc. / Z-1027-2014

Z-1027-2014 Class II Terminated

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-1027-2014 was initiated by Zimmer, Inc. on Oct 11, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Apr 14, 2017). Affected quantity: 7,044,680 total.

Recall Details

Product Type: Devices
Report Date: Feb 26, 2014
Initiation Date: Oct 11, 2013
Termination Date: Apr 14, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,044,680 total

Product Description

PRESSFIT FEM ST FX 16 X 1

Reason for Recall

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.

Distribution Pattern

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.

Code Information

60621428 60667768

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1027-2014
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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