Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a p
FDA device recall Z-0226-2015 · posted 2014-11-26 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- Two nonconforming parts of the Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws may have been inadvertently packaged and shipped. It is believed that the inner diameter of the Reduction Head may not have been machined to the correct specification.
- Action taken
- DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated October 23, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check inventory and remove affected stock, call Synthes to obtain a Return Authorization for the device, and to return the completed verification section of the response form by fax to (610) 430-7083 or Scan/email: Fieldaction@synthes.com. Customers with questions were instructed to call 610-719-5450.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 24
- Distribution
- Distributed to MI, MT, and CO.
- Date initiated
- 2014-10-23
- Date posted
- 2014-11-26
- Date terminated
- 2015-08-10
- Location
- West Chester, PA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SYNTHES MATRIX SYSTEM (K100952) | Synthes Spine | 2010-08-05 |