Recalls / —
—#131023
Product
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).
- FDA product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K100952
- Affected lot / code info
- Part Number 04.634.002 Lot Number 6816781
Why it was recalled
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 (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Synthes (USA) Products LLC
- Address
- 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986
Distribution
- Distribution pattern
- Distributed to MI, MT, and CO.
Timeline
- Recall initiated
- 2014-10-23
- Posted by FDA
- 2014-11-26
- Terminated
- 2015-08-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #131023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.