OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Reported: January 22, 2025 Initiated: November 27, 2024 #Z-0919-2025
Product Description
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Reason for Recall
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Details
- Recalling Firm
- IsoTis OrthoBiologics, Inc.
- Units Affected
- 145
- Distribution
- US Nationwide distribution in the states of AL, CA, MD. MN, MS, NC, NV, OH, OK, TX.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.. Recalled by IsoTis OrthoBiologics, Inc.. Units affected: 145.
Why was this product recalled? ▼
Hydration issue resulting in the product being less cohesive and moldable than intended due to an issue with the polymer.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Moderate. Recall number: Z-0919-2025.
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