FDAClass IIApril 24, 2013

OsteoSelect DBM Putty Product Usage: Orthopedic bone recall

OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

Why was OsteoSelect DBM Putty Product Usage: Orthopedic bone recalled?

The firm's retesting procedure was not validated.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

B100164 and B110115

Product
OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
Recalling firm
Bacterin International, Inc.
Quantity
165
Distribution
USA Nationwide Distribution
Recall date
April 24, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls