REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-
FDA device recall Z-0628-2014 · posted 2014-01-03 · Terminated
Recall details
- Recalling firm
- Materialise USA LLC
- Reason for recall
- Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
- Action taken
- Materialise USA LLC notified the Field Representative on November 26, 2013 of the recall by phone followed by E-mail notification. The notification identified the device and reason for the recall. Notification directions included instructions to find and quarantine the device and return it Materialise. A replacement device was shipped November 27, 2013 receiving the defective device was called, followed by E-mail notification the Recall, which identified the device, problem, and instructed the distributor to find and quarantine product. For questions regarding this recall call 734-662-5057.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HRY
- Quantity affected
- 1
- Distribution
- US Distribution: MO only.
- Date initiated
- 2013-11-26
- Date posted
- 2014-01-03
- Date terminated
- 2014-01-14
- Location
- Plymouth, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIGNATURE PLANNER / SIGNATURE GUIDES (K110415) | Materialise NV | 2011-05-16 |