Recall Z-1138-2013— Bacterin International, Inc.

Name: FDA recall Z-1138-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-21

Class II · Terminated

Class II FDA medical device recall by Bacterin International, Inc., initiated 2013-02-21, terminated 2013-07-01. It names one FDA 510(k) clearance: K091321. Product: OsteoSelect DBM Putty Product Usage: Orthopedic bone filler. Reason: The firm's retesting procedure was not validated..

Recalling firm: Bacterin International, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-21
Terminated: 2013-07-01
Firm location: Belgrade, MT, United States

510(k) clearances named in this recall

1 on FDA's record

K091321 — OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.·cleared 2009-09-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

Reason for recall

The firm's retesting procedure was not validated.

Data sourced from openFDA. This site is unofficial and independent of the FDA.