Z-1361-2022Class II

ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605

Name: Z-1361-2022 ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Creator: Science & Bio Materials
Published: 2021-10-07
License: https://open.fda.gov/license/

Science & Bio Materials, S.B.M. SAS / initiated 2021-10-07 / Completed / root cause: manufacturing process

FDA source

SCIENCE & BIO MATERIALS began a recall of ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605 on 2021-10-07. FDA classified it as Class II and gives the reason as "Mislabeled product". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1361-2022
Classification: Class II
Status: Completed
Initiated: 2021-10-07
Posted: 2022-07-08
Recalling firm: Science & Bio Materials, S.B.M. SAS
Product: ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
Product code: HWC Screw, Fixation, Bone
Reason for recall: Mislabeled product.
Root cause tag: manufacturing process
FDA 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 in commerce: 72 units
Distribution: US Nationwide distribution.
Product codes and lots: Product code: 110004605; Lot #: 190491, Use before 01/01/2022. GTIN 03760154006767

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1361-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1361-2022	Class II	Completed	Voluntary: Firm initiated	2022-07-20	2022-07-08

Product code HWC

K070507Class IIModification to: Ligafix Interference ScrewScience For Biomaterials / cleared 2007-03-29

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)