Recall Z-0533-2020 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Zimmer Biomet, Inc.
BIOMOD PORCOAT HA GLENTRAY; Custom Shoulder Products Item Nos. PM0000097 PM555140 PM555147 PM555319 PM555418 113867 113865 113863 Product Usage: Total Shoulder Replacement
| Date | Aug 21, 2019 |
| Status | Terminated |
| Reason | Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue. |
| Root cause | Environmental control |
| Action | On September 11, 2019, the firm began notifying distributors and customers of the recall via an Urgent Medical Device Recall letter. The letter informed consignees of the product issue. Customers were asked to assist their Zimmer Biomet sales representative and quarantine all identified product. The sales representative will remove the product from your facility. If any products were further distributed, please forward the notification to responsible parties. If you have further questions or concerns, please call customer service at 574-371-3071 between 8:00 am and 5:00 pm ET, Monday throug |
| Quantity | 214741 |
| Distribution | US Nationwide distribution and countries of Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043100 | BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS Biomet, Inc., Feb 17, 2005 |