Z-0986-2012

Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow...

Name: Z-0986-2012 Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow...
Creator: Integra LifeSciences Corp
Published: 2011-10-07
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2011-10-07 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp began a recall of 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... on 2011-10-07. The reason FDA records is "Integra OS Osteoconductive Putty is labeled with incorrect storage conditions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0986-2012
Status: Terminated
Initiated: 2011-10-07
Posted: 2012-02-08
Terminated: 2013-05-21
Recalling firm: Integra LifeSciences Corporation
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.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
Root cause tag: labeling and UDI
FDA 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 in commerce: 45 units
Distribution: Nationwide Distribution - Including the states of CA, OK, MD and VA.
Product codes and lots: 2.5 cc Part numbers - IOS10125 Lot numbers - N199416 and 215944 5 cc Part numbers - lOS10155 Lot numbers - 208500, 206504 and N216026

Product code MQV

K062353Class IIMozaik Bone Regeneration Matrix - PuttyIntegra LifeSciences Corporation / cleared 2006-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)