FDA Device recall Z-1293-2013
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for…
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for… by Integra Lifesciences, citing due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1293-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-28 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for Dental Surgery are intended for use on moist or bleeding oral wounds where a stabilized blood clot can help protect the surface of the wound from further injury. Topical administration of the Absorbable Collagen Wound Dressings directly over the wound effectively controls bleeding usually within two to five minutes.
Reason
Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Identifiers
| code_info | 1104500, 1104623 1105315, 1105316 1105317, 1110234 1110235, 1110236 1110237, 1110238 1110239, 1110240 1110784, 11…1104500, 1104623 1105315, 1105316 1105317, 1110234 1110235, 1110236 1110237, 1110238 1110239, 1110240 1110784, 1111151 1111152, 1111153 1111155, 1111156 1111157, 1111646 1105300 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1293-2013%22
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