Offset Femoral Alignment Guide 4mm x 6; Product Code: KS 67024 Product Usage: The instrumentation has been designed to f
FDA device recall Z-2455-2015 · posted 2015-08-24 · Terminated
Recall details
- Recalling firm
- Omnilife Science Inc.
- Reason for recall
- The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur.
- Action taken
- Omni sent an Urgent Medical Device -Field Safety Notice letters to their customers. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to Return the attached Acknowledgement and Receipt Form by FAX to 508-819-3390.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FZX
- Quantity affected
- 15
- Distribution
- Worldwide Distribution - US Nationwide in the states of OK, CO, OH, MA and the countries of Spain and Australia.
- Date initiated
- 2015-06-09
- Date posted
- 2015-08-24
- Date terminated
- 2015-09-28
- Location
- East Taunton, MA
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