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.
This recall has been terminated (originally issued November 21, 2014).
- Company
- Materialise Usa Llc
- Recall Initiated
- October 16, 2014
- Posted
- November 21, 2014
- Terminated
- February 17, 2015
- Recall Number
- Z-0418-2015
- Quantity
- 1
- Firm Location
- Plymouth, MI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution to MN only
Lot / Code Info
00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
Root Cause
Nonconforming Material/Component
Action Taken
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.