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Terminated

Bayonet Electrosurgical Pencil. P/N 9560575. The product is shipped in cases containing 100 blades/pencils.

FDA Recall Z-1150-2007 · Posted 2007-08-14

Recalling FirmZinnanti Surgical Design LLC
Recall StatusTerminated
Product CodeGEI
Date Initiated2007-07-12
Date Terminated2008-03-07
Product Quantity8, 860 units

Reason for Recall

Bubble Leak Test Failure of sterility barrier, therefore sterility of the device may be compromised

Firm Action

The recalling firm issued an Urgent Medical Device Recall Letter dated 7/24/07 to its single wholesaler requesting recall and sub-recall to all their consignees.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K930511STEALTH SURGICAL IRRIGATOR ASPIRATORW. J. Medical Instruments, Inc. · 1993-06-25

Official Source

View FDA Recall →

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

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