FDA Medical Device Recalls (openFDA)
Materialise USA LLC: Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
- Recall number
- Z-0418-2015
- Recalling firm
- Materialise USA LLC
- Product
- Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
- Status
- Terminated
- Initiated
- 2014-10-16
- Posted
- 2014-11-21
- Terminated
- 2015-02-17
- Reason
- The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
- Root cause
- Nonconforming Material/Component
- Action
- Materialise USA was notified on October 16, 2014 by the Field Representative of the distributor (Zimmer) that the box of guides for case JTOMA-JL-0636-L arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. A new set of tibial and femoral guides were manufactured and sent to Zimmer (headquarters distribution center) on October 17, 2014 before the surgery date on October 20, 2014. For questions regarding this recall call 734-662-5057.
- Quantity
- 1
- Distribution
- Nationwide Distribution to MN only
- Lot, serial or model codes
- 00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
- 510(k) numbers
- ["K121640"]
- 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