Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Reported: February 21, 2018 Initiated: August 3, 2017 #Z-0597-2018
Product Description
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Reason for Recall
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Details
- Recalling Firm
- OrthoPediatrics Corp
- Units Affected
- 24 units
- Distribution
- US Nationwide Distribution
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation. Recalled by OrthoPediatrics Corp. Units affected: 24 units.
Why was this product recalled? ▼
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2018. Severity: Moderate. Recall number: Z-0597-2018.
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