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Terminated

Fix pins associated with Stealth Station Treatment Guidance Platform

FDA Recall Z-0231-04 · Posted 2003-12-17

Recalling FirmMedtronic Surgical Navigation Tech, Inc
Recall StatusTerminated
Product CodeHAW
Date Initiated2003-10-31
Date Terminated2003-12-19
Product Quantity127 devices

Reason for Recall

Surgical devices intended for single use were not labeled for single use.

Firm Action

Consignees were notified by letter on 11/01/2003.

Root Cause

Other

Distribution Pattern

Domestic distribution to CA,FL,GA,KS,TX. Foreign distribution to Belgium, France, Germany, Hong Kong, Japan. No military or government consignees.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030552IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEMMedtronic Surgical Navigation Technologies · 2003-03-19K021980HIP MODULE FOR THE STEALTHSTATION SYSTEMMedtronic Surgical Navigation Technologies · 2002-11-19K012937KNEE MODULE FOR THE STEALTHSTATION SYSTEMMedtronic Surgical Navigation Technologies · 2002-01-25K001153MODIFICATION TO STEATHSTATION TREATMENT GUIDANCE PLATFORMMedtronic Surgical Navigation · 2000-05-03

Official Source

View FDA Recall →

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

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