Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used a
FDA device recall Z-1287-2015 · posted 2015-03-17 · Terminated
Recall details
- Recalling firm
- Materialise N.V.
- Reason for recall
- Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
- Action taken
- Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1 unit
- Distribution
- Worldwide Distribution to the Netherlands only.
- Date initiated
- 2015-02-04
- Date posted
- 2015-03-17
- Date terminated
- 2015-10-30
- Location
- Heverlee, Belgium
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNATURE PLANNER; SIGNATURE GUIDES (K102795) | Materialise NV | 2011-02-02 |