FDA Medical Device Recalls (openFDA)
Materialise N.V.: Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
- Recall number
- Z-0162-2016
- Recalling firm
- Materialise N.V.
- Product
- Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
- Status
- Terminated
- Initiated
- 2015-09-23
- Posted
- 2015-10-23
- Terminated
- 2016-02-12
- Reason
- Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
- Root cause
- Use error
- Action
- On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was followed up by e-mail notification letter with response forms. Biomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be Customer Service Materialise USA LLC 44650 Helm Court Plymouth, Michigan 48170 734-259-7033
- Quantity
- 4
- Distribution
- Distributed in MI, ID, TX, and in France.
- Lot, serial or model codes
- 42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03
- 510(k) numbers
- ["K102795"]
- PMA numbers
- not on file
- Product code
- OSF
- 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