—#178707

Product

ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: 827310, 711160, 203240

Why it was recalled

Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach

Root cause (FDA determination)

Process control

Action the firm took

Zimmer Biomet issued letter via email and FedEx on 12/17/19 stating reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 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: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS

Timeline

Recall initiated: 2019-12-19
Terminated: 2020-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #178707. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.