FDA Medical Device Recalls (openFDA)
SCIENCE & BIO MATERIALS: ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
- Recall number
- Z-1361-2022
- Recalling firm
- SCIENCE & BIO MATERIALS
- Product
- ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
- Status
- Completed
- Initiated
- 2021-10-07
- Posted
- not on file
- Terminated
- not on file
- Reason
- Mislabeled product.
- Root cause
- Process control
- Action
- The firm notified its US distributor of the recall by email on 30 September 2021. The notice requested quarantine of the device and for the distributor to notify all interested parties with their organization and to any organization to which the device was transferred.
- Quantity
- 72 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767
- 510(k) numbers
- ["K070507"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3004051158
- Firm city
- Lourdes
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28