Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fra
FDA device recall Z-2278-2013 · posted 2013-09-25 · Terminated
Recall details
- Recalling firm
- Synthes USA HQ, Inc.
- Reason for recall
- Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276).
- Action taken
- Synthes sent an Urgent Notice Medical Device Recall letter dated March 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to obtain a Return Authorization Number, complete the Verification Section at the end of the letter by the checking the appropriate box indicating affected product located. Return the Verification Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email Fieldaction@synthes.com. For questions regarding this recall call 610-719-5000.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 2
- Distribution
- Nationwide Distribution including CA,and VA. .
- Date initiated
- 2013-03-08
- Date posted
- 2013-09-25
- Date terminated
- 2015-05-21
- 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 |
|---|---|---|
| 3.5 MM LCP DISTAL HUMERUS SYSTEM (K033995) | Synthes (Usa) | 2004-03-01 |