PATIENT SPECIFIC INSTRUMENTS LPS-FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID--0242-LF Manufactured by Materialise, Plymouth, MI Distributed by Zimmer, Warsaw IN. Patient specific instrument 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
Hazard
March 23, 2012 a field representative reported patient specific -0242-L tibia guide case packaging contained a different patient specific -0864-R tibia guide. The two patient specific products had been switched in packaging. Neither products had been delivered to the end user.
What You Should Do
Remedy
Materialise telephoned both field representatives on March 23, 2012 and confirmed recalled product mix-up. Materialise requested both cases be returned and replacements were provided. No affected product was received by the end user.
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Products
PATIENT SPECIFIC INSTRUMENTS
LPS-FLEX PIN GUIDES (FEMUR AND TIBIA)
NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE
Patient ID--0242-LF
Manufactured by Materialise, Plymouth, MI
Distributed by Zimmer, W
- Brand
- Materialise USA LLC
- UPC
- Lot 56529819, REF 005970-000-02 Exp 2012-09-06
Units Affected
1 unit