Z-2886-2020Class II

Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the...

Name: Z-2886-2020 Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the...
Creator: Materialise N.V.
Published: 2020-07-17
License: https://open.fda.gov/license/

Materialise N.V. / initiated 2020-07-17 / Terminated / root cause: software

FDA source

Materialise N.V. began a recall of 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... on 2020-07-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2886-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-17
Posted: 2020-08-26
Terminated: 2020-12-23
Recalling firm: Materialise N.V.
Product: 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.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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.
Root cause tag: software
FDA root cause: Software Design Change
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].
Quantity in commerce: 128
Distribution: Nationwide distribution to: US including PR and International to UK and Australia.
Product codes and lots: ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2886-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2886-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-26

Product code KWS

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)