FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp: Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.
- Recall number
- Z-0986-2012
- Recalling firm
- Integra LifeSciences Corp
- Product
- Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.
- Status
- Terminated
- Initiated
- 2011-10-07
- Posted
- 2012-02-08
- Terminated
- 2013-05-21
- Reason
- Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
- Root cause
- Error in labeling
- Action
- Integra issued an "Urgent: Product Recall Notification" to customers and sales specialists on 10/7/2011. They were advised of the problem and provided instructions on how to handle the affected product.
- Quantity
- 45 units
- Distribution
- Nationwide Distribution - Including the states of CA, OK, MD and VA.
- Lot, serial or model codes
- 2.5 cc Part numbers - IOS10125 Lot numbers - N199416 and 215944 5 cc Part numbers - lOS10155 Lot numbers - 208500, 206504 and N216026
- 510(k) numbers
- ["K062353"]
- PMA numbers
- not on file
- Product code
- MQV
- 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