—#115816

Product

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.

FDA product code: MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K992739
Affected lot / code info: Lot Number 7542279

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

Distribution pattern: Distributed in the states of AL, CA, MS, MO, NJ, OR, and TN.

Timeline

Recall initiated: 2013-01-11
Posted by FDA: 2013-03-11
Terminated: 2015-09-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115816. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.