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Terminated

Surgical Pattie, 1/4" x 1/4" Non--Sterile (Each Unit of sales is 100 cards) of patties on each card) Product code: 24-5403

FDA Recall Z-0095-2011 · Posted 2010-10-20

Recalling FirmCodman & Shurtleff, Inc.
Recall StatusTerminated
Product CodeHBA
Date Initiated2010-07-16
Date Terminated2012-07-09
Product Quantity229 boxes (100 cards/10 patties each card)

Reason for Recall

Surgical Pattie x-ray stripe (radio-opaque marker) may become detached

Firm Action

Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460.

Root Cause

Process control

Distribution Pattern

Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K880402CODMAN SURGICAL PATTIECodman & Shurtleff, Inc. · 1988-03-02

Official Source

View FDA Recall →

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

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