REF 42-411571 QTY 1 CATALOG CAUTION — Class II medical device recall Z-0628-2014
Terminated recall by Materialise USA LLC, reported 2014-01-15. Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
| Recall number | Z-0628-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Materialise USA LLC, Plymouth, MI, United States |
| Recall initiated | 2013-11-26 |
| Classified | 2014-01-03 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-01-14 |
| Quantity | 1 |
| Lot numbers | 094929 |
| Model numbers | 42-411571 |
Product
REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.
Reason for recall
Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0628-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.