5100-03-707 -- MOST Option STEM DISTRACTOR MATL: SS NONSTERILE QTY-1 Designed to facilitate intraoperative decisions with a variety of options for femoral and tibial components, implant connections and fixation of the implants.
FDA Recall Z-0861-2012 · Posted 2012-01-25
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2011-11-15
Date Terminated2013-09-24
Product Quantity70
Reason for Recall
Fractured tips: Any use of force in a certain direction to the flat side of the instrument may result in fracturing of the mating geometry, creating the potential for metal debris at the surgical site.
Firm Action
Urgent Device Correction Letters, dated October 28, 2011, which included revised Surgical Technique to be used in the Zimmer Most Option Wedge Stem Distractor were sent November 15, 2011 to all Distributors requiring Correction letters be sent to all Hospital Risk Managers and Surgeons receiving devices. Directions were provided to destroy all previous versions of the surgical technique, and review the attached revised surgical technique, with warnings of proper direction of force needed for safe separation of mated components. A FAX -Back Certificate of Acknowledgement is to be sent to (574) 372-4265. Call Zimmer at 1-877-946-2761 with questions or concerns.
Root Cause
Labeling False and Misleading
Distribution Pattern
Worldwide Distribution -- US, including states of TX, IN, GA, WI, MN, NJ, MO, IL, VA, MI, PA, NC, OR, FL, KS, NY, AZ, CO, and UT and country of Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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