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Terminated

OsteoSelect DBM Putty Product Usage: Orthopedic bone filler

FDA Recall Z-1138-2013 · Posted 2013-04-17

Recalling FirmBacterin International, Inc.
Recall StatusTerminated
Product CodeMBP
Date Initiated2013-02-21
Date Terminated2013-07-01
Product Quantity165

Reason for Recall

The firm's retesting procedure was not validated.

Firm Action

Bacterin sent a Voluntary Product Recall Notification letter via e-mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are being asked to return any remaining product by obtaining a Return Authorization number from them. Bacterin is also asking customers to return the verification form mailed with the recall letter regardless of whether or not they had any product on hand. For questions contact Bacterin sales representative or Bacterin Customer Service.

Root Cause

Process control

Distribution Pattern

USA Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091321OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc. · 2009-09-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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