Recall Z-2060-2012 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes USA HQ, Inc.
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
| Date | Jul 23, 2012 (initiated May 22, 2012) |
| Status | Terminated |
| Reason | Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 20 |
| Distribution | Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103002 | SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM Synthes (Usa), Mar 2, 2011 |