CLASS II Device recall · Reported 20 Jul 2022 · FDA Enforcement Report
ComposiTCP 30 Interference screw D recalled by Science & Bio Materials
Science & BIO Materials is recalling ComposiTCP 30 Interference screw D, distributed nationwide in the US. The recall was initiated on 7 Oct 2021 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-1361-2022
- FDA event ID
- 90281
- Recalling firm
- Science & BIO Materials, Lourdes
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 7 Oct 2021
- FDA classified
- 8 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 7 Oct 2021 | Recall initiated by company | |
| 8 Jul 2022 | Classified by FDA | +274 days |
| 20 Jul 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeled product.
Product as listed by the FDA
ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Mislabeled product.
Which lots are affected?
Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767
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 26 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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