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Terminated

Hem-o-LokSMX Legating Clip, REF 544220, Lot 988384, Non-absorbable Polymer Ligation Clips, Sterile EO, Weck Closure Systems, Research Triangle Park, NC 27709, Sterile, Single use, Disposable.

FDA Recall Z-0547-04 · Posted 2004-02-25

Recalling FirmWeck
Recall StatusTerminated
Product CodeFZP
Date Initiated2004-01-23
Date Terminated2004-05-11
Product Quantity70 sales units

Reason for Recall

Malformation of the Hem-o-lok SMX clip.

Firm Action

Consignees were notified by letter via Federal Express (Domestic consignees), Email (International and Weck Sales Representatives), and Fax (Weck Sales Representatives) beginning 01/23/2004.

Root Cause

Other

Distribution Pattern

Distributors and hospitals in AL, CA, FL, MA, MD, MI, NC, NY, OH, OR, PA, SC, TX, Korea and France

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982941HEM-O-LOK MODEL NUMBERS 523900, 523970Weck Closure Systems · 1998-11-19

Official Source

View FDA Recall →

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

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