FDA Medical Device Recalls (openFDA)
IsoTis OrthoBiologics, Inc.: OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
- Recall number
- Z-0919-2025
- Recalling firm
- IsoTis OrthoBiologics, Inc.
- Product
- OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
- Status
- Open, Classified
- Initiated
- 2024-11-27
- Posted
- 2025-01-15
- Terminated
- not on file
- Reason
- Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
- Root cause
- Under Investigation by 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 danielle.becker@seaspine.com or Danielle Nelson-Archer at danielle.nelson-archer@seaspine.com.
- Quantity
- 145
- Distribution
- US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
- Lot, serial or model codes
- OsteoCove Putty, REF 56920013, UDI-DI: 10889981309022, Lot Numbers: 180054, Exp. 2025-08-28; 180054R18, Exp. 2025-08-28; 179604R18, Exp. 2024-12-28; 180484, Exp. 2026-02-28; 180370, Exp. 2026-01-28; 180299, Exp. 2025-11-28; 180075, Exp. 2025-08-28; and Cove Putty, REF 02-9200-013, UDI-DI: 10889981308933, Lot Number: 180075R18, Exp. 2025-08-28.
- 510(k) numbers
- ["K242273"]
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3001503333
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28