CLASS II Device recall · Reported 22 May 2013 · FDA Enforcement Report
CollaCote Absorbable Collagen Wound Dressing recalled
Integra LifeSciences is recalling CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen, distributed nationwide in the US. The recall was initiated on 28 Mar 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1292-2013
- FDA event ID
- 64778
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Mar 2013
- FDA classified
- 10 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Device type
- Dental Devices
Timeline
| 28 Mar 2013 | Recall initiated by company | |
| 10 May 2013 | Classified by FDA | +43 days |
| 22 May 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
CollaCote 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.
Where it was distributed
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1125684, 1125685 1125689, 1126014 1104963, 1110481 1110791, 1110792 1111363, 1111644 1110673, 1111856
Where was it sold?
Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
20 other products · FDA event 64778This product is part of a recall event; the main page for the event is Ora Plug Absorbable Collagen Wound Dressing recalled.
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| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
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