—#162220

Product

Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

FDA product code: JDC — Prosthesis, Elbow, Constrained, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K001989
Affected lot / code info: Lot Number: 63694912

Why it was recalled

One lot of humeral stem implants do not include the humeral bushing components.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

1. Immediately locate and quarantine affected product in your inventory. 2. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. Request a Return Authorization Number. Mark RECALL on the outside of the returned cartons.

Recalling firm

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

Distribution

Distribution pattern: Distributed in China and Taiwan.

Timeline

Recall initiated: 2018-01-24
Posted by FDA: 2018-03-14
Terminated: 2019-04-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162220. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.