Reported Nov 4, 2015 · Terminated
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for…
Materialise N.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Materialise N.V. · 15 Technologielaan · Heverlee, N/A · N/A
Is this the product you have?
- Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
- Lot codes and dates
- 42422461: Signature SIG CT/TI(A Guides 04-05 Slidex
- Distal-MP/Premier Tibial & 42422551Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03
- Amount recalled
- 4
Where it was sold
Why it was recalled
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
This product could cause temporary or reversible health problems — stop using it.
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