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Open, Classified

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

FDA Recall Z-0919-2025 · Posted 2025-01-15

Recalling FirmIsoTis OrthoBiologics, Inc.
Recall StatusOpen, Classified
Product CodeMQV
Date Initiated2024-11-27
Product Quantity145

Reason for Recall

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

Firm Action

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 [email protected] or Danielle Nelson-Archer at [email protected].

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K242273Cove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation · 2024-09-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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