MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet Patient Specific Instruments (PSI)-- patient-matched dev
FDA device recall Z-2213-2023 · posted 2023-07-20 · Completed
Recall details
- Recalling firm
- Materialise N.V.
- Reason for recall
- The wrong tibia guide was included intended for a different patient case.
- Action taken
- Materialise notified Zimmer Biomet international logistics on April 26, 2023 via email and telephone requested return of cases. Zimmer BIomet confirmed that they would directly contact the customer to return the original cases ZB23-MAN-OLA and ZB22-UHI-NEF. Materialise shipped replacement cases on May 2, 2023 and May 3, 2023. For questions call +1-734-259-7010 or email: zimmerbiomet@materialise.com.
- Root cause
- Process control
- Status
- Completed
- Product code
- JWH
- Quantity affected
- 2 Guides
- Distribution
- International Distribution to countries of: Germany, Netherlands
- Date initiated
- 2023-04-26
- Date posted
- 2023-07-20
- Location
- Heverlee, Belgium
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Materialise TKA Guide System (K221337) | Materialise NV | 2022-07-05 |
| Materialise TKA Guide System (K173445) | Materialise NV | 2018-02-02 |