FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

Products

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
Brand
Zimmer Biomet, Inc.
UPC
Lot Numbers: 827310, 711160, 203240

Units Affected

67 units