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Terminated

TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.

FDA Recall Z-0440-2007 · Posted 2006-12-30

Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeMQV
Date Initiated2006-09-29
Date Terminated2007-08-09
Product Quantity32

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040047POLYGRAFT BGS; BONE GRAFT SUBSTITUTEOsteobiologics, Inc. · 2004-12-17

Official Source

View FDA Recall →

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

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