DePuy Orthopaedics, Inc. Recall 87189
Description: Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
DePuy Orthopaedics, Inc. Recall 87189 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1103-2021 |
| Event ID | 87189 |
| Event Description | Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland. |
| Quantity | 60 sleeves |
| Recall Reason | The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. |
| Device Classification | 20210217 |
| Device Code Info | Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92 |
| Center Classification Date | 20210209 |
| Recall Initiation Date | 20210108 |
| Recalling Firm | DePuy Orthopaedics, Inc. |
| Initial Notification | Letter |
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