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Terminated

T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.

FDA Recall Z-1295-03 · Posted 2003-10-15

Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeHSB
Date Initiated2003-08-04
Date Terminated2003-09-30
Product Quantity6

Reason for Recall

The device does not have an oblong hole for dynamic locking as required.

Firm Action

Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt.

Root Cause

Other

Distribution Pattern

The 6 units were distributed to Howmedica Branch and sales agents located in PA, VA, GA, KS, and CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K003018TITAN TIBIAL NAILHowmedica Osteonics Corp. · 2000-12-15

Official Source

View FDA Recall →

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

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