Home / Recalls / Bacterin International, Inc. / Z-1138-2013

Z-1138-2013 Class II Terminated

Recalled by Bacterin International, Inc. — Belgrade, MT

Recall Details

Product Type
Devices
Report Date
April 24, 2013
Initiation Date
February 21, 2013
Termination Date
July 1, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
165

Product Description

OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

Reason for Recall

The firm's retesting procedure was not validated.

Distribution Pattern

USA Nationwide Distribution

Code Information

B100164 and B110115

Other recalls by Bacterin International, Inc.

  • Z-1396-2015 Class II — Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used t (March 9, 2015)
  • Z-1680-2014 Class II — Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wo (May 15, 2014)
  • Z-0936-2013 Class II — Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubles (January 28, 2013)
  • Z-0800-2013 Class II — Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; (April 18, 2012)