—#124603

Product

VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4 and X 5, VERSA-FX SHORT TUBE, 130D, 135D and 140D, VERSA-FX STANDARD TUBE, 1 and VERSA-FX SPRCNDLR TUBE, 9 Item codes starting with 001980, 001981, 0011990 and 0011991

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: 60053473 60528659 60807849 60855076 365855 60807850 60855077 365856 60143351 60384033 60403721 60452546 60543211 60632720 60807851 368913 369123 60219007 60740783 60993433 365857 369559 371074 60539739 60807852 365859 60098398 60119108 60241936 60625494 60082810 60625506 365860 365861 60222477 60109715 60187232 366023 60161891 60116180 60175536 365749 60082811 60109716 60123966 60175537 60231394 60097992 60119110 60123967 60143352 60154511 60165702 60175538 60231395 365740 366424 60109717 60112053 60112054 60116181 60116182 60119111 60119112 60129316 60129317 60154512 60154513 60165703 60175539 60187233 60187234 60206858 60206859 60241934 60161892 365739 60109718 365738 60123968 366024 366025 60136407 365752 365751 60123969 60154514 60082812 60109719 365753 365743 60163222

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.

Root cause (FDA determination)

Packaging

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

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.

Timeline

Recall initiated: 2013-10-11
Posted by FDA: 2014-02-20
Terminated: 2017-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124603. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.