FDA Medical Device Recalls (openFDA)
Materialise N.V.: 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.
- Recall number
- Z-2886-2020
- 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.
- Status
- Terminated
- Initiated
- 2020-07-17
- Posted
- not on file
- Terminated
- 2020-12-23
- Reason
- 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
- 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: Jenny.Jones@materialise.com.
- Quantity
- 128
- Distribution
- Nationwide distribution to: US including PR and International to UK and Australia.
- Lot, serial or model codes
- ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022 UDI #s: E314804030570, E314804251480, E314804070220
- 510(k) numbers
- ["K153602","K170893"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 3003998208
- Firm city
- Heverlee
- Firm state
- not on file
- Firm country
- Belgium
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28