Recall Z-0226-2015 ยท NKB Thoracolumbosacral Pedicle Screw System
Synthes (USA) Products LLC
Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws: The Titanium Polyaxial Reduction Head is a part of the Matrix Spine System. Intended for posterior pedicle screw fixation (Tl OS2- ilium), posterior hook fixation (Tl-L5), or anterolateral fixation (T8-L5).
| Date | Nov 26, 2014 (initiated Oct 23, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 24 |
| Distribution | Distributed to MI, MT, and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100952 | MODIFICATION TO SYNTHES MATRIX SYSTEM Synthes Spine, Aug 5, 2010 |