—#110194

Product

4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-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).

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K103002
Affected lot / code info: Lot #2721745 Expiration 4/29/2012 REF 04.019.028S

Why it was recalled

Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.

Timeline

Recall initiated: 2012-05-22
Posted by FDA: 2012-07-23
Terminated: 2015-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110194. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.