Biomet, Inc. Recall 89544
Description: Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Biomet, Inc. Recall 89544 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0670-2022 |
| Event ID | 89544 |
| Event Description | Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands. |
| Quantity | 19 units |
| Recall Reason | The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor. |
| Device Classification | 20220302 |
| Device Code Info | Lot Number: 853650, 853810 UDI: (01)00880304468030(17) 290122(10)853650; (01)00880304468030(17) 290211(10)853810 |
| Center Classification Date | 20220224 |
| Recall Initiation Date | 20220107 |
| Recalling Firm | Biomet, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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