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Terminated

Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.

FDA Recall Z-0171-04 · Posted 2004-07-20

Recalling FirmStryker Instruments, Instruments Div.
Recall StatusTerminated
Product CodeFPK
Date Initiated2003-11-12
Date Terminated2004-05-03
Product Quantity15

Reason for Recall

Product sterility may have been compromised by an inadequate package seal.

Firm Action

Recall letters dated 11/12/03 were issued to each customer and sales representatives were requested to question each account about affected product.

Root Cause

Other

Distribution Pattern

United States, France and United Kingdom.

Official Source

View FDA Recall →

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

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