—#105072

Product

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 product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K002324
Affected lot / code info: Lots 1519123, 1616672, 1627174, 60281712, 60773654, 60795066, 60841064, 61061148, 61348637, and 61770544.

Why it was recalled

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 (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

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

Distribution

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.

Timeline

Recall initiated: 2011-11-15
Posted by FDA: 2012-01-25
Terminated: 2013-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #105072. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.