FDA Device Recall Z-0041-05: Linvatec Corp.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0041-05.

Recall Res Number

Z-0041-05

Recalling Firm / Manufacturer

Linvatec Corp.

FEI Number

1017294

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2004-08-26

Date Posted

2004-10-23

Date Terminated

2012-07-06

Product Code

HRX

Event Number

29916

Product Quantity

58510 units

Product Description Ultra Power Burs, Sterile, Single-Use.

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

Action Details 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.

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

Code Information / Serial Numbers All product with an expiration date between August 2004 and August 2009.

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Medical Device Recall: Z-0041-05

Recall Parameters & Description

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