Recall Z-0919-2025— IsoTis OrthoBiologics, Inc.

Name: FDA recall Z-0919-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-27

Class II · Ongoing

Class II FDA medical device recall by IsoTis OrthoBiologics, Inc., initiated 2024-11-27. It names one FDA 510(k) clearance: K242273. Product: OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.. Reason: Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer..

Recalling firm: IsoTis OrthoBiologics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-27
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K242273 — Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation·cleared 2024-09-25

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

OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.

Reason for recall

Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.

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