Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO
FDA device recall Z-2661-2017 · posted 2017-06-12 · Terminated
Recall details
- Recalling firm
- Medacta Usa Inc
- Reason for recall
- One lot of product does not include a screw for attachment to the tibial base plate.
- Action taken
- On 5/19/17 all distributors with recalled product were immediately notified of the recall by email. On 5/23/17, all distributors were further notified of the recall via phone. On 5/30/17, a third notification was completed via phone.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 4 units
- Distribution
- CA, AZ, NC, Israel, France
- Date initiated
- 2017-05-19
- Date posted
- 2017-06-12
- Date terminated
- 2018-05-29
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GMK HINGE (K130299) | Medacta International | 2013-08-15 |