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Terminated

ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773

FDA Recall Z-0711-2008 · Posted 2008-04-08

Recalling FirmLinvatec Corp.
Recall StatusTerminated
Product CodeGFF
Date Initiated2007-08-09
Date Terminated2009-10-01
Product Quantity1181 units

Reason for Recall

Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package may have compromised sterility due to an improper seal.

Firm Action

Conmed Linvatec sent their consignees Urgent New Recall Medical Device Recall Notification letters On August 9, 2007 by UPS overnight delivery. The letter requests the customer return the devices to Linvatec for credit. Domestic Distributors / Sales Representatives were notified by telephone and email.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K781979SURGAIRTOME TWOAmerican Sterilizer Co. · 1978-12-20

Official Source

View FDA Recall →

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

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