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).
Recall
- Recall Number
- Z-2059-2012
- Event Number
- 62307
- Firm
- Synthes USA HQ, Inc.
- FEI Number
- 3005180112
- Product Code
- HSB
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- May 22, 2012
- Posted
- July 23, 2012
- Terminated
- September 10, 2015
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
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).
Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
Synthes sent a "NOTICE: MEDICAL DEVICE RECALL" letter dated May 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Verification Form was enclosed for customers to complete and return via fax to 610-251-9005. Contact the firm at 610-719-5450 for questions regarding this recall.
Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.
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