Zimmer, Inc. Recall 90858
Description: G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Zimmer, Inc. Recall 90858 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0007-2023 |
| Event ID | 90858 |
| Event Description | G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty |
| Product Type | Devices |
| Distribution | Domestic distribution US nationwide. |
| Quantity | 56 US |
| Recall Reason | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention. |
| Device Classification | 20221012 |
| Device Code Info | Item No. 010000663 UDI-DI: 00880304524224 Lots: 7286477 7289929 7296576 7296633 7301697 Exp. 21-Jul-32 Item No. 010000667 UDI-DI: 00880304524262 Lot: 7253325 Exp. 13-Jun-32 |
| Center Classification Date | 20221005 |
| Recall Initiation Date | 20220825 |
| Recalling Firm | Zimmer, Inc. |
| Initial Notification | Letter |
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