—#168457

Product

Zimmer ZMS Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lots expiring prior to September 30, 2023

Why it was recalled

Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer Biomet conducted recall to distributors and hospital risk managers on 10/22/18, distributors notified via email. Hospital risk managers, as well as distributors with product, will be notified via Fed'X." Distributors responsibilities include:- Locating and removing the product in their territory, as well as identifying hospitals with fielded inventory. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Ensuring affected personnel are aware of the notice contents - Assisting the Zimmer Biomet sales representative with the quarantine of the affected products. Certificate of Acknowledgement complete and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN

Timeline

Recall initiated: 2018-10-22
Terminated: 2020-12-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168457. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.