Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1037-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

FEM HD ION (various sizes)

Product Classification:

Class II

Date Initiated: October 11, 2013

Date Posted: February 26, 2014

Recall Number: Z-1037-2014

Event ID: 66500

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.

Status: Terminated

Product Quantity: 7,044,680 total

Code Information:

61401713 60282649 60291491 60362702 60586125 60977398 61089134 62051714 60530561 60759915 60939995 61275826 60169621

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.

Voluntary or Mandated:

Voluntary: Firm initiated