PATIENT SPECIFIC INSTRUMENTS N-K FLEX PIN GUIDES (FEMUR AND TIBIA) NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE Patient ID ..- 0864-R3 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 implant are identifiable on patient image scans.
This recall has been terminated (originally issued May 14, 2012).
- Company
- Materialise Usa Llc
- Recall Initiated
- March 23, 2012
- Posted
- May 14, 2012
- Terminated
- January 23, 2013
- Recall Number
- Z-1544-2012
- Quantity
- 1 unit
- Firm Location
- Plymouth, MI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution including the states of Ohio and Minnesota.
Lot / Code Info
Lot 56529886, REF 005970-000-03 Exp 2012-09-08
Root Cause
Labeling mix-ups
Action Taken
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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