—#180027

Product

Comprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage: The intended use of the comprehensive humeral stem mini is to act as the humeral component of the comprehensive total shoulder system.

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: Lot No. 659260, UDI Number: (1)00880304462649(17)290814(10)659260

Why it was recalled

A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

URGENT MEDICAL DEVICE FIELD SAFETY NOTICE-REMOVAL letter dated February 17, 2020 was sent via email to consignees. The letter identified affected product, problem and the action to be taken. Customers were advised 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. 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 field safety notice for hospitals and ensure documentation. 4.Complete Attachment 1 Certification of Acknowledgement Form and send to fieldaction.emea@zimmerbiomet.com.This form must be returned even if you do not have affected products available to return in your facility. 5.Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facilitys documentation. 6. If you have further questions or concerns after reviewing this notice, please contact your Zimmer Biomet representative. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: Med Watch Reporting: Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs Med Watch Adverse Event Reporting program either online, by mail, or by fax. Online: www.fda.gov/medwatch/report.htm Mail: Use postage paid, pre-addressed form FDA 3500, available at: www.fda.gov/MedWatch/getforms.htm Fax: 1-800-FDA-0178 Under 21 CFR 803, manufacturers are required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep Zimmer Biomet informed of any adverse events associated with this product or any other Zimmer Biomet product by emailing product.experience@zimmerbiomet.com.

Recalling firm

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

Distribution

Distribution pattern: International distribution in the countries of Canada, Japan, Netherlands, South Korea.

Timeline

Recall initiated: 2020-02-17
Posted by FDA: 2020-03-03
Terminated: 2022-05-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #180027. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.