Z-0919-2025Class II

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

Name: Z-0919-2025 OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01
Creator: IsoTis OrthoBiologics, Inc.
Published: 2024-11-27
License: https://open.fda.gov/license/

IsoTis OrthoBiologics, Inc. / initiated 2024-11-27 / Open, Classified

FDA source

IsoTis OrthoBiologics, Inc. began a recall of OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01 on 2024-11-27. FDA classified it as Class II and gives the reason as "Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0919-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-27
Posted: 2025-01-15
Recalling firm: IsoTis OrthoBiologics, Inc.
Product: OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
FDA 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 [email protected] or Danielle Nelson-Archer at [email protected].
Quantity in commerce: 145
Distribution: US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0919-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0919-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-15

Product code MQV

K242273Class IICove Putty, OsteoCove PuttySeaSpine Orthopedics Corporation / cleared 2024-09-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)