CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Response 5/6.0 Spine System Pedicle Screw recalled by OrthoPediatrics
OrthoPediatrics is recalling Response 5/6.0 Spine System Pedicle Screw, distributed nationwide in the US. The recall was initiated on 3 Aug 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0597-2018
- FDA event ID
- 79067
- Recalling firm
- OrthoPediatrics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2017
- FDA classified
- 13 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 3 Aug 2017 | Recall initiated by company | |
| 13 Feb 2018 | Classified by FDA | +194 days |
| 21 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Product as listed by the FDA
Response 5.5/6.0 Spine System 7.0mm x 40mm Pedicle Screw Product Usage: Posterior non-cervical pedicle screw fixation
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Response 5/6.0 Spine System Pedicle Screw recalled?
Yes. OrthoPediatrics recalled Response 5/6.0 Spine System Pedicle Screw on 3 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0597-2018.
Why was it recalled?
The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
Which lots are affected?
Model number: 00-1300-0740, Lot number: M82791-1
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
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