—#48857

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.

FDA product code: MQV — Filler, Bone Void, Calcium Compound
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: 051024-14 and 011-051024-14.

Why it was recalled

Mis-packaging-product in the package may be a different size than indicated on the labeling.

Root cause (FDA determination)

Other

Action the firm took

Firm notified customers of recall by letter sent via FedEx on 09/29/06.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT.

Timeline

Recall initiated: 2006-09-29
Posted by FDA: 2006-12-30
Terminated: 2007-08-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48857. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.