—#128909

Product

Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Item Number 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896

Why it was recalled

The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.

Root cause (FDA determination)

Device Design

Action the firm took

On July 23, 2014, Zimmer issued recall notification to their consignees. Distributors were notified via electronic mail and courier. Recall notification included a description of the issue, affected product, possible risks to patient, and instructions for responding to the recall. Questions or concerns regarding the recall are directed to Zimmer customer call center @ 1-800-348-2759 M-F, 8am-8pm ET.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.

Timeline

Recall initiated: 2014-07-23
Posted by FDA: 2014-08-14
Terminated: 2015-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #128909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.