Recall Z-0861-2012 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Zimmer Inc.
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.
| Date | Jan 25, 2012 (initiated Nov 15, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling False and Misleading |
| 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) |
| Quantity | 70 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002324 | MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA Sulzermedica, Aug 24, 2000 |