4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthe
FDA device recall Z-2059-2012 · posted 2012-07-23 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 20
- Distribution
- Nationwide Distribution-including the states of AZ, CA, FL, GA, IL, LA, MD, MN, NJ, NY, OH, PA, TN, TX, and VA.
- Date initiated
- 2012-05-22
- Date posted
- 2012-07-23
- Date terminated
- 2015-09-10
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM (K103002) | Synthes (Usa) | 2011-03-02 |