OMNIlife science Inc. Recall 87062
Description: SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928
OMNIlife science Inc. Recall 87062 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0922-2021 |
| Event ID | 87062 |
| Event Description | SERF Novae Dual Mobility Cup Insert 49/28-ApeX-LNK Poly Liner. Intended for use with the Apex Modular Acetabular Cup for total hip replacement procedures. Product Code: H6-24928 |
| Product Type | Devices |
| Distribution | AL, ID, MD, NY, OK |
| Quantity | 2 units |
| Recall Reason | Acetabular Liners have a higher than acceptable oxidation limit, potential for patients to experience a higher wear rate for acetabular liners and require a revision surgery |
| Device Classification | 20210203 |
| Device Code Info | Lot Number: 28572 |
| Center Classification Date | 20210126 |
| Recall Initiation Date | 20201221 |
| Recalling Firm | OMNIlife science Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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