Materialise recalls Match Point System surgical instruments due to incorrect procedure side labeling in Shoulder Case Planning Reports, which could lead to surgical errors.
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.
Materialise is recalling its Match Point System surgical instruments because the Shoulder Case Planning Report incorrectly labels the procedure side as 'Left' for right-sided surgeries. This could cause surgical errors if the wrong side is used during operations.
The Shoulder Case Planning Report incorrectly indicates the procedure side as 'Left' when it should be 'Right' for right-sided surgeries. This mismatch could lead to using the wrong side during surgery, potentially causing errors in the procedure.
Surgical teams using the Match Point System for shoulder replacements may be affected. Patients undergoing shoulder surgery with this system are at risk of incorrect surgical procedures.
Check for the ID numbers: 804-03-057, 804-25-148, 804-03-058, 804-07-022. The UDI numbers are E314804030570, E314804251480, E314804070220.
Verify the ID numbers: 804-03-057, 804-25-148, 804-03-058, 804-07-022.
The Shoulder Case Planning Report incorrectly labels the procedure side as 'Left' for right-sided surgeries, which could lead to surgical errors.
Check the product ID numbers to see if your item is affected. If it is, contact Materialise for further instructions.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Materialise to request your refund or repair — edit it as you like.
Subject: Recall Z-2886-2020 — Materialise Materialise Hello, I own a Materialise that is covered by recall Z-2886-2020 from Materialise. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
