Reported Aug 5, 2020 · Terminated
MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial…
Synthes Produktions GmbH
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: Synthes Produktions GmbH · Eimattstrasse 3 · Oberdorf Bl, N/A · N/A
Is this the product you have?
- MatrixMIDFACE Screws - Product UsageThe intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin
- Lot codes and dates
- Lot # 41P2340
- Amount recalled
- 41 units
Why it was recalled
One lot of MatrixMIDFACE Emergency Screw 1.8mm, self-tapp, L 12mm, in Clip was packaged with a body clip etched with a 3 (representing 3mm) when it should have been packaged with body clip etched with a 12 (representing 12mm).
This product could cause temporary or reversible health problems — stop using it.
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