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Terminated

Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

FDA Recall Z-0008-04 · Posted 2003-10-15

Recalling FirmRultract Inc
Recall StatusTerminated
Product CodeDWS
Date Initiated2003-09-18
Date Terminated2007-03-23
Product Quantity2,718 units

Reason for Recall

Component spring or nut may loosen, detach, and fall into chest of patient during surgical procedure.

Firm Action

The firm notified their affected consignees by letter on 9/18/2003.

Root Cause

Other

Distribution Pattern

The device was distributed to end-users located nationwide.

Official Source

View FDA Recall →

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

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