OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty… recallZ-0919-2025 · IsoTis OrthoBiologics, Inc. · initiated Nov 27, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from IsoTis OrthoBiologics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-0919-2025
- Status
- Open, Classified
- Initiated by the company
- Nov 27, 2024
- Posted by the FDA
- Jan 15, 2025
- Recalling firm
- IsoTis OrthoBiologics, Inc.
- Quantity
- 145
- Product code
- MQV
- FDA submissions
- K242273
- Distribution
- US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Product description
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cove 02-9200-013Seaspine Orthopedics Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
- OsteoCove 56920013Seaspine Orthopedics Corporation · FILLER, BONE VOID, CALCIUM COMPOUND1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page