Ethicon Endo-Surgery Endopath ETS-Flex Articulating Endoscopic Linear Cutter, 35mm Standard, Product #ATB35.
This recall has been terminated (originally issued December 17, 2003).
- Company
- Ethicon Endo-Surgery
- Recall Initiated
- November 25, 2003
- Posted
- December 17, 2003
- Terminated
- May 9, 2012
- Recall Number
- Z-0212-04
- Quantity
- 16,962
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
A defective articulation band may result in improper staple formation with possible hematosis.
Distribution
The product was shipped to hospitals and distributors located nationwide and worldwide.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.