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Terminated

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.

FDA Recall Z-2886-2020 · Posted None

Recalling FirmMaterialise N.V.
Recall StatusTerminated
Product CodeKWS
Date Initiated2020-07-17
Date Terminated2020-12-23
Product Quantity128

Reason for Recall

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.

Firm Action

The firm, materialise, sent Recall letters dated 17 July 2020 informing customers of the issue. This letter informs the customer that Materialise has corrected the Shoulder Case Planning Report in the SurgiCase online system. If you have any questions, contact Global Quality and Regulatory Manager Medical, at 734-259-7017 or email: [email protected].

Root Cause

Software Design Change

Distribution Pattern

Nationwide distribution to: US including PR and International to UK and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K170893Materialise Glenoid Positioning SystemMaterialise NV · 2017-06-19K153602Materialise Glenoid Positioning SystemMaterialise NV · 2016-04-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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