Bacterin International, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1138-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.
Product Description:

OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

Product Classification:

Class II

Date Initiated: February 21, 2013
Date Posted: April 24, 2013
Recall Number: Z-1138-2013
Event ID: 64486
Reason for Recall:

The firm's retesting procedure was not validated.

Status: Terminated
Product Quantity: 165
Code Information:

B100164 and B110115

Distribution Pattern:

USA Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated