—#197703

Product

OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K042409
Affected lot / code info: UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620

Why it was recalled

Product missing the four small locking collar bolts resulting in extension of surgery to find a replacement

Root cause (FDA determination)

Process control

Action the firm took

****UPDATE***Phase II Zimmer Biomet issued Urgent Medical Device Recall Letter (Removal) on March 7, via FedEx to the Distributor and Risk Manager. Letter states health risk and action to take: Risk Manager Responsibilities: 1. 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. If the product has been further distributed, provide your customers with the recall notice for hospitals and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. If you have further 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. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Zimmer Biomet is conducting the recall in a phased approach due to limited replacement products for the Modular Arthrodesis Nail Collar Assembly (PN: CP260602) and due to the ability to separately purchase the small locking collar bolts (PN: CP260603).Letter to Distributors via email on 11/29/22 states: Replacement Small Locking Collar Bolts (Part Number: CP260603) will be sent to your territory. Replacement orders were placed today, November 29, with overnight delivery to your main territory office (Phase 1) Once replacement devices are availab

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: US Nationwide distribution in the states of CA, KY, FL.

Timeline

Recall initiated: 2022-11-29
Posted by FDA: 2023-01-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.