IsoTis OrthoBiologics, Inc. recalls OsteoCove Putty

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

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

An Urgent Medical Device Recall notice dated 11/27/2024 was issued via email. The notice advises customers to discontinue use, review inventory on hand for the referenced lots, and return the affected part(s) to SeaSpine using the attached label to return the inventory. Once inventory has been returned, please acknowledge via DocuSign. Direct questions regarding this matter to Danielle Becker at danielle.becker@seaspine.com or Danielle Nelson-Archer at danielle.nelson-archer@seaspine.com.

• FDA enforcement recordOfficial FDA database entry for Z-0919-2025
• FDA 510(k) clearance · K242273The device's official FDA premarket clearance record
• FDA device classification · MQVOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3045The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find IsoTis OrthoBiologics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.