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Terminated

Shaver Handpiece Sterilization Tray. Model number 272-700-000. For sterilization of Stryker Endoscopy arthroscopic shaver.

FDA Recall Z-1872-2014 · Posted 2014-06-25

Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHRX
Date Initiated2014-05-19
Date Terminated2015-05-07
Product Quantity1992 trays

Reason for Recall

STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) did not fully consider all worst-case scenarios during validation testing.

Firm Action

Device Correction letters were sent on May 23, 2014 to all users by certified mail. Internation sites will receive notification and be responsible for contacting customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K941333SE5 ARTHROSCOPY SYTEMStryker Endoscopy · 1994-11-10

Official Source

View FDA Recall →

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

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