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Terminated

Long Length Dyax Nail.

FDA Recall Z-0256-06 · Posted 2005-12-01

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeNDH
Date Initiated2004-09-07
Date Terminated2006-10-03
Product Quantity4

Reason for Recall

Stryker became aware that Catalog number 1594-1130S, Lot Code K559623 was manufactured with a lag screw hold angulation of 135 degrees rather than 130 degrees.

Firm Action

The firm sent out notification letters via FedEx on 9/7/2004 with return receipt.

Root Cause

Other

Distribution Pattern

The devices were distributed to Stryker branches and agencies. These are Stryker sales representatives located nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013468LONG LENGTH DYAX NAILHowmedica Osteonics Corp. · 2001-11-16

Official Source

View FDA Recall →

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

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