FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corporation: OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
- Recall number
- Z-1298-2013
- Recalling firm
- Integra LifeSciences Corporation
- Product
- OraMem Absorbable Collagen Membrane OraMem Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.
- Status
- Terminated
- Initiated
- 2013-03-28
- Posted
- 2013-05-10
- Terminated
- 2015-06-03
- 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.
- Root cause
- Process control
- Action
- The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: FCA@integralife.com or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if you have already implanted or used collagen sponge products affected by this recall, we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol." For assistance or any other questions that you may have, please contact Customer Service at 1-855-532-1723.
- Quantity
- 812 boxes
- Distribution
- 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.
- Lot, serial or model codes
- 1112066
- 510(k) numbers
- ["K924408"]
- PMA numbers
- not on file
- Product code
- LYC
- Firm FEI
- 1121308
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28