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U.S. Department of Health and Human Services

Class 2 Device Recall OsteoCove Putty

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 Class 2 Device Recall OsteoCove Puttysee related information
Date Initiated by FirmNovember 27, 2024
Date PostedJanuary 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0919-2025
Recall Event ID 95978
510(K)NumberK242273 
Product Classification Filler, bone void, calcium compound - Product Code MQV
ProductOsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Code Information 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.
FEI Number 3001503333
Recalling Firm/
Manufacturer		 IsoTis OrthoBiologics, Inc.
2 Goodyear Ste A
Irvine CA 92618-2052
For Additional Information ContactSeaSpine Complaints
760-216-5122
Manufacturer Reason
for Recall		Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
FDA Determined
Cause 2		Under Investigation by firm
ActionAn 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 in Commerce145
DistributionUS Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MQV
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