Recalls / —
—#106839
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.
- FDA product code
- MQV — Filler, Bone Void, Calcium Compound
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K062353
- Affected lot / code info
- 2.5 cc Part numbers - IOS10125 Lot numbers - N199416 and 215944 5 cc Part numbers - lOS10155 Lot numbers - 208500, 206504 and N216026
Why it was recalled
Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
Root cause (FDA determination)
Error in labeling
Action the firm took
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.
Recalling firm
- Firm
- Integra LifeSciences Corp
- Address
- 105 Morgan Ln, Plainsboro, New Jersey 08536-3339
Distribution
- Distribution pattern
- Nationwide Distribution - Including the states of CA, OK, MD and VA.
Timeline
- Recall initiated
- 2011-10-07
- Posted by FDA
- 2012-02-08
- Terminated
- 2013-05-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #106839. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.