Z-0443-2007

TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured...

Name: Z-0443-2007 TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured...
Creator: Smith & Nephew, Inc. Endoscopy Division
Published: 2006-09-29
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2006-09-29 / Terminated / root cause: labeling and UDI

FDA source

Smith & Nephew, Inc. Endoscopy Division began a recall of TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX on 2006-09-29. The reason FDA records is "Mis-packaging-product in the package may be a different size than indicated on the labeling". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0443-2007
Status: Terminated
Initiated: 2006-09-29
Posted: 2006-12-30
Terminated: 2007-08-09
Recalling firm: Smith & Nephew, Inc.
Product: TruFit BGS Plug Size Code Blue, 9mm; quantity 1; Part #600-001-05; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Mis-packaging-product in the package may be a different size than indicated on the labeling.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Firm notified customers of recall by letter sent via FedEx on 09/29/06.
Quantity in commerce: 34
Distribution: Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT.
Product codes and lots: 051024-14 and 011-051024-14.

Product code MQV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)