—#168913

Product

Comprehensive Mini Stem, Item No. 113631:

FDA product code: MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060692
Affected lot / code info: 568150

Why it was recalled

Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On October 10, 2018, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were advised of the product issue. Distributors were asked to take the following actions: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. If the affected product is located at a hospital, remove the product from the hospital and provide the Risk Manager Recall Notice to the hospital and request that they sign the Certificate of Acknowledgement. 4. Immediately return all affected product from your distributorship and from affected hospitals within your territory along with hospital Certificate of Acknowledgement. a. For each return, complete Attachment 1 Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. d. Mark RECALL on the outside of the returned cartons. 5. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. a. Review the list of hospitals included with the email notification sent to your facility. b. Identify whether there are any additional hospitals that Zimmer Biomet is not aware of and list these accounts on the Additional Accounts form. Please provide the form in Excel format. c. If there are no additional accounts to notify, please indicate that there are no additional accounts, or indicate None or NA on the form. Hospital Risk Managers were asked to take the following actions: 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

Recalling firm

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

Distribution

Distribution pattern: Distributed to accounts in IN, MD, MO, MS, and NM.

Timeline

Recall initiated: 2018-10-10
Terminated: 2020-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168913. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.