Terminated

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.

FDA Recall Z-1544-2012 · Posted 2012-05-14

Recalling FirmMaterialise USA LLC

Recall StatusTerminated

Product CodeJWH

Date Initiated2012-03-23

Date Terminated2013-01-23

Product Quantity1 unit

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.

Firm Action

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.

Root Cause

Labeling mix-ups

Distribution Pattern

Nationwide Distribution including the states of Ohio and Minnesota.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K111492ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTSMaterialise NV · 2011-10-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.