—#89992

Product

Zimmer Reconstruction System Offset Clamp Tips 4.5 cm Offset, Item # 00-1179-028-03, Zimmer Inc., Warsaw, IN. Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.

FDA product code: HWN — Instrument, Compression
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: lot #'s: 60699507, 60616321, and 60964870.

Why it was recalled

The firm determined that the recalled instruments were manufactured using the wrong grade of material. As manufactured, the instruments are more brittle, increasing the potential for fracture.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Zimmer sent an Urgent Device Recall letter dated February 16, 2010, to all affected customers. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to monitor all potentially affected patients through regular office consultations. Ensure Zimmer Reconstruction System Tenaculum System Instrument Users at their facility were informed of the urgent device recall. Locate all instruments and quarantine them immediately. Count all affected product in their territory and record the data on the Inventory Return Certification Form included with the letter. Fax a copy of the completed Inventory Return Form to: Zimmer, Inc. at (574) 372-4265. Return the recalled product along with the original completed Inventory Return Certification Form to: Zimmer Distribution Center Attn: Product Service 1777 West Center Street Warsaw, IN 46580 For questions customers were instructed to contact their Zimmer Sales Representative. For questions regarding this recall call 1 - (800) 613-6131.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,

Timeline

Recall initiated: 2010-02-16
Posted by FDA: 2010-12-01
Terminated: 2011-10-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.