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U.S. Department of Health and Human Services

Class 2 Device Recall Endopath ETSFlex Articulating Endoscopic Linear Cutter

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 Class 2 Device Recall Endopath ETSFlex Articulating Endoscopic Linear Cuttersee related information
Date Initiated by FirmNovember 25, 2003
Date PostedDecember 17, 2003
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-0212-04
Recall Event ID 27763
510(K)NumberK020779 K961390 
Product Classification Staple, Implantable - Product Code GDW
ProductEthicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.
Code Information Lot Numbers: T4VP02, T4VU1R, T4VV8G, T4VY38, T4W14P, T4W31X, T4W40L, T4W49R, T4W78J, T4W94K, T4W94L, T4WD1Z, T4WE79, T4WG29, T4WH7T, T4WP20, T4WP6M, T4WR1U, T4WV5C, T4WV5D, T4WX38, T4WY96, T4WY9P, T4WZ5H, T4X06W, T4X19X, T4X19Y, T4X21T, T4X54V, T4X84D, T4XC4X, T4XC4Y, T4XD42, T4XD46, T4XE9P, T4XF1L, T4XM0T, T4XM0U, T4XN1K, T4XV2R, T4XV2T, T4XW1U, T4XW1V, T4XZ65, T4Y28Z, T4Y465, T4Y466, T4Y77P, T4Y801.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information ContactMr. Dirk Stevens
513-337-7501
Manufacturer Reason
for Recall		A defective articulation band may result in improper staple formation with possible hematosis.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.
Quantity in Commerce16,962
DistributionThe product was shipped to hospitals and distributors located nationwide and worldwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GDW
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