FDA Medical Device Recalls (openFDA)
Bacterin International, Inc.: OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
- Recall number
- Z-1138-2013
- Recalling firm
- Bacterin International, Inc.
- Product
- OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
- Status
- Terminated
- Initiated
- 2013-02-21
- Posted
- 2013-04-17
- Terminated
- 2013-07-01
- Reason
- The firm's retesting procedure was not validated.
- Root cause
- Process control
- 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.
- Quantity
- 165
- Distribution
- USA Nationwide Distribution
- Lot, serial or model codes
- B100164 and B110115
- 510(k) numbers
- ["K091321"]
- PMA numbers
- not on file
- Product code
- MBP
- Firm FEI
- 3005031160
- Firm city
- Belgrade
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28