Reported Sep 2, 2020 · Terminated
Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the…
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. · Technologielaan 15 · Heverlee, N/A · N/A
Is this the product you have?
- Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.
- Lot codes and dates
ID #s: 804-03-057804-25-148804-03-05880407022 UDI #s: E314804030570E314804251480E314804070220
- Amount recalled
- 128
Where it was sold
- Nationwide
- PR
Why it was recalled
The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
This product could cause temporary or reversible health problems — stop using it.
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