Device product
4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
Z-2059-2012
Product summary
- Event
- Event 62307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20
- Official record key
device-enforcement:Z-2059-2012
Official wording
Reason: Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
Code information: Lot #2724103 Expiration 4/29/2012 REF 04.019.038S
Distribution pattern: Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.
Derived failure modes
-
Labeling or packaging
incorrect labeling