—#138110

Product

Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

FDA product code: MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051216
Affected lot / code info: Catalog Number 28202, Lot Number AS05107

Why it was recalled

Incorrect thread form on the screw.

Root cause (FDA determination)

Device Design

Action the firm took

Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Distributed in the states of FL, GA, IL, NY, TX, and WA.

Timeline

Recall initiated: 2009-03-06
Posted by FDA: 2015-07-10
Terminated: 2015-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138110. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.