Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
- Company
- Orthopediatrics Corp
- Recall Initiated
- August 3, 2017
- Terminated
- May 8, 2019
- Recall Number
- Z-0597-2018
- Quantity
- 24 units
- Firm Location
- Warsaw, IN
Reason for Recall
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Distribution
US Nationwide Distribution
Lot / Code Info
Model number: 00-1300-0740, Lot number: M82791-1
Root Cause
Employee error
Action Taken
On August 4, 2017 an urgent medical device recall letter, titled "Response 5.5/6.0 Spine System - 7.0mm x 40mm UNIAXIAL PEDICLE SCREW" was issued to customers with instruction to quarantine affected product, which will be returned to the recalling firm for destruction. Questions or concerns can be directed to logistics@orthopediatrics.com or calling (574) 268-3692
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