Biomet, Inc. Recall 87201
Description: Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation.
Biomet, Inc. Recall 87201 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1131-2021 |
| Event ID | 87201 |
| Event Description | Central Screw 6.5x25mm - Product Usage: used as a sterile screw that is intended for implantable shoulder prosthesis assembly and/or fixation. |
| Product Type | Devices |
| Distribution | US Nationwide distribution including in the states of MS, MN, KY, FL, MI, OH, AZ, IL, WI, CA, UT, TN. |
| Quantity | 49 |
| Recall Reason | Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 MM length central screw was packaged and labeled as a 25 MM length central screw. |
| Device Classification | 20210224 |
| Device Code Info | Model No.: 115395, Lot No.: 077170, UDI: (01) 00880304677074 (17) 301010 (10) 077170 |
| Center Classification Date | 20210217 |
| Recall Initiation Date | 20210115 |
| Recalling Firm | Biomet, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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