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Terminated

Ultra Power Burs, Sterile, Single-Use.

FDA Recall Z-0041-05 · Posted 2004-10-23

Recalling FirmLinvatec Corp.
Recall StatusTerminated
Product CodeHRX
Date Initiated2004-08-26
Date Terminated2012-07-06
Product Quantity58510 units

Reason for Recall

The pouch containing the sterile product is not completely seal on all products. Therefore , the sterility of the device is questionable.

Firm Action

Each consignee will be notified by telephone, email, letter or UPS overnight delivery. They will be asked to return the affected product to Linvatec, Largo, Florida for credit or no-cost replacement. A returned goods authorization number will be assigned for the returned product.

Root Cause

Packaging process control

Distribution Pattern

Distributed to 492 customers throughout the United States, and 301 customers internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981636INTEGRATED DRIVE/PUMP SYSTEMLinvatec Corp. · 1998-08-20K781979SURGAIRTOME 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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