Synthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- January 11, 2013
- Posted
- March 11, 2013
- Terminated
- September 10, 2015
- Recall Number
- Z-0938-2013
- Quantity
- 18
- Firm Location
- West Chester, PA
Reason for Recall
Lot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
Distribution
Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
Lot / Code Info
Lot Number 7542279
Root Cause
Employee error
Action Taken
The firm initiated a recall of this product on January 11, 2013 by sending an Urgent Notice: Medical Device Recall letter, dated January 11, 2013, to all consignees. The letter identified the affected product and the issue, as well as requested that consignees examine their inventory for the product(s) with the identified Part and Lot Numbers, remove them from use, and return them to Synthes. Customers were to follow the steps provided in the letter regarding if they had or did not have any of the identified affected product. Questions were to be directed to 610-719-5450 or Fieldaction@synthes.com.