FDA Medical Device Recalls (openFDA)
Materialise USA LLC: Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
- Recall number
- Z-1941-2016
- Recalling firm
- Materialise USA LLC
- Product
- Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
- Status
- Terminated
- Initiated
- 2016-05-03
- Posted
- not on file
- Terminated
- 2016-06-28
- Reason
- A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
- Root cause
- Process control
- Action
- Materialise sent an URGENT: Signature Personalized Patient Care System Knee Guides Notification dated May 3, 2016. It was sent to the affected customer via email with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Contact Materialise customer service for additional information or to find a status of the second patient specific surgical guide Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.734-259-7016
- Quantity
- 1
- Distribution
- One consignee, Indiana.
- Lot, serial or model codes
- Lot #154970
- 510(k) numbers
- ["K102795"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3005718816
- Firm city
- Plymouth
- Firm state
- MI
- Firm country
- not on file
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