Recall Z-1543-2020 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Biomet, Inc.
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.
| Date | Mar 3, 2020 (initiated Feb 17, 2020) |
| Status | Terminated |
| Reason | A 15mm Shoulder Mini Humeral Stem was misidentified as a 9mm Shoulder Mini Humeral Stem. |
| Root cause | Under Investigation by firm |
| Action | 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 not |
| Quantity | 14 units |
| Distribution | International distribution in the countries of Canada, Japan, Netherlands, South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060692 | COMPREHENSIVE PRIMARY SHOULDER STEMS Biomet Manufacturing Corp, May 30, 2006 |