Recall Z-1361-2022— SCIENCE & BIO MATERIALS

Name: FDA recall Z-1361-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-07

Class II · Completed

Class II FDA medical device recall by SCIENCE & BIO MATERIALS, initiated 2021-10-07. It names one FDA 510(k) clearance: K070507. Product: ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605. Reason: Mislabeled product..

Recalling firm: SCIENCE & BIO MATERIALS
Classification: Class II
Status: Completed
Initiated: 2021-10-07
Firm location: Lourdes, France

510(k) clearances named in this recall

1 on FDA's record

K070507 — MODIFICATION TO: LIGAFIX INTERFERENCE SCREWScience For Biomaterials·cleared 2007-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Mislabeled product.

Data sourced from openFDA. This site is unofficial and independent of the FDA.