FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc. Endoscopy Division: TruFit CB Plug Size Code Blue, 9mm; quantity 1; Part #605-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
- Recall number
- Z-0441-2007
- Recalling firm
- Smith & Nephew, Inc. Endoscopy Division
- Product
- TruFit CB Plug Size Code Blue, 9mm; quantity 1; Part #605-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
- Status
- Terminated
- Initiated
- 2006-09-29
- Posted
- 2006-12-30
- Terminated
- 2007-08-09
- Reason
- Mis-packaging-product in the package may be a different size than indicated on the labeling.
- Root cause
- Other
- Action
- Firm notified customers of recall by letter sent via FedEx on 09/29/06.
- Quantity
- 28
- Distribution
- Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT.
- Lot, serial or model codes
- 051024-14 and 011-051024-14.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MQV
- Firm FEI
- 3003604053
- Firm city
- Andover
- Firm state
- MA
- 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