Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is u
FDA device recall Z-0404-2014 · posted 2013-11-26 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.
- Action taken
- Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 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 call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by: Fax: 866-229-7778 Scan/email: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- JDS
- Quantity affected
- 55
- Distribution
- Nationwide Distribution
- Date initiated
- 2013-10-14
- Date posted
- 2013-11-26
- Date terminated
- 2015-08-18
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (K111667) | Synthes (Usa) | 2011-12-05 |