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Terminated

Gamma3 Long Nail Kit, 120 degree, 11 x 320mm Right. And 125 degree Nail.

FDA Recall Z-0241-06 · Posted 2005-12-01

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeNDH
Date Initiated2004-11-22
Date Terminated2006-10-03
Product Quantity19

Reason for Recall

The Gamma Nail may have been manufactured with an incorrect lag screw hole angulation. Catalog number 3225-0360S, lot code K949396 was manufactured with a lag screw hole angulation of 120 degrees instead of 125 degrees. Catalog number 3220-0320S, lot code K949408 was manufactured with a lag screw hole angulation of 125 degrees instead of 120 degrees.

Firm Action

Notification letters and Product Accountability forms were sent via FedEx on 11/22/2004 with return receipt.

Root Cause

Other

Distribution Pattern

The product was sent to Stryker Orthopaedics branches and agents throughout the US. There was one hospital that was a direct account.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K034002GAMMA3 NAIL SYSTEMHowmedica Osteonics Corp. · 2004-01-15

Official Source

View FDA Recall →

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

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