FDA · Medical device recall

Endopath EZ45 Endoscopic Linear Cutter (EZ45B) and 5 more products

Feb. 1, 2005

Date posted by the FDA: Feb. 1, 2005
Status: Terminated
Filed by: Ethicon Endo-Surgery
Reason: The product may cause an incomplete staple line to be formed and, therefore, not provide expected control of the tissue.
Distribution pattern: The product was distributed to hospitals and distributors throughout the United States and to foreign customers located in Korea, China, Republic of Singapore, Argentina, Italy, New Zealand, Austria, Canada, Australia, Brazil, United Arab Emirate, Thailand, Czech Republic, Sweden, Switzerland, Greece, Russia, India, Portugal, Israel, Poland, Hungary, and Uruguay.

6 products in this recall

Endopath EZ45 Endoscopic Linear Cutter (EZ45B)

Product: Endopath EZ45 Endoscopic Linear Cutter (EZ45B)
Quantity: 3179 devices.
Codes and lots: EZ45B: lots T4XE79, T4XF7F, V40043, V40378, V40379, V4080M, V4083P, V40C1U, V40H0Y, V40K5V, V40W6T, V40X9X, V41831, V4197Y, V41A4M, V41C3Z, V41C98, V41E71, V41F9Y, V41U9F, V41Y80, V42105, V42220, V4231R, V4262Z, V4270F, V42C7P, V42G1X, V42K0X, V42MOT, V42P6P, V42V2R, V42Y1J, V42Z8Z, V43231, V43521, V4ZE36, V4ZE39, V4ZJ35, V4ZK34, V4ZV7W, V4ZX2N.
Recall started: Nov. 21, 2004
Device type: Staple, Implantable
Root cause (FDA): Other
What the company told customers: The firm sent letters, dated 11/21/04, to all consignees.
Recall number: Z-0457-05

Endopath EZ45 No Knife Linear Stapler (NK45B)

Product: Endopath EZ45 No Knife Linear Stapler (NK45B).
Quantity: 65 devices.
Codes and lots: NK45B: lots T4X84Z, V4ZM09.
Recall started: Nov. 21, 2004
Device type: Staple, Implantable
Root cause (FDA): Other
What the company told customers: The firm sent letters, dated 11/21/04, to all consignees.
Recall number: Z-0458-05

Endopath EZ45 Endoscopic Linear Cutter (EZ45G)

Product: Endopath EZ45 Endoscopic Linear Cutter (EZ45G).
Quantity: 5687 devices.
Codes and lots: EZ45G: lots T4XE2M, T4XE5A, T4XN8A, V4011N, V4011N, V4041X, V4092A, V40C1V, V40D3K, V40G4K, V40L3L, V40N9M, V40V5M, V40W1G, V40Y7X, V41031, V4179G, V4188D, V4197Z, V41A60, V41C25, V41C71, V41E2X, V41E5R, V41F9T, V41L7L, V41M2K, V41R2T, V41U9J, V41Y64, V41Z5L, V42221, V4231M, V4262Y, V4271Y, V42744, V4282L, V42C5L, V42G1Y, V42H1C, V42H9A, V42K6L, V42M08, V42M6Y, V42R1A, V42T7C, V42X1R, V4303Y, V4399, V4348J, V4369E, V4ZC23, V4ZE3U, V4ZE3Z, V4ZG8G, V4ZH7M, V4ZP6K, V4ZU1M, V4ZX9Z.
Recall started: Nov. 21, 2004
Device type: Staple, Implantable
Root cause (FDA): Other
What the company told customers: The firm sent letters, dated 11/21/04, to all consignees.
Recall number: Z-0459-05

Endopath EZ45 Endoscopic Linear Cutter (ET45B)

Product: Endopath EZ45 Endoscopic Linear Cutter (ET45B).
Quantity: 1249 devices.
Codes and lots: ET45B: lots V40491, V402JG, V40L7G, V40Y0V, V40Z4T, V4115D, V41C2J, V41H9Z, V4238R, V42503, V42D7L, V42G6T, V42H1R, V42K6M, V42P09, V42U6G, V42Z26, V42Z27, V4Z72F, V4ZK9P, V4ZR8Y.
Recall started: Nov. 21, 2004
Device type: Staple, Implantable
Root cause (FDA): Other
What the company told customers: The firm sent letters, dated 11/21/04, to all consignees.
Recall number: Z-0460-05

Endopath EZ45 Endoscopic Linear Cutter (ET45G)

Product: Endopath EZ45 Endoscopic Linear Cutter (ET45G).
Quantity: 1456 devices.
Codes and lots: ET45G: lots T4X78R, T4XEO2, T4YH24, V4Z686, V4Z687, V40493, V4083R, V40E8C, V40J36, V40L12, V40X9T, V41143, V41832, V41A4H, V41U9L, V42505, V42C8X, V42G6R, V42H22, V42K6N, V42L0H, V42M83, V42P08, V42V6G, V42X1P, V42X6J, V4307T, V4ZL7F, V4ZY12, V40Z2Y, .
Recall started: Nov. 21, 2004
Device type: Staple, Implantable
Root cause (FDA): Other
What the company told customers: The firm sent letters, dated 11/21/04, to all consignees.
Recall number: Z-0461-05

Endopath EZ45 No Knife Linear Stapler (NK45G)

Product: Endopath EZ45 No Knife Linear Stapler (NK45G).
Quantity: 199 devices.
Codes and lots: NK45G: lots: V40Z1C, V41M2N, V42H3V, V4Z42W, V4ZU1N.
Recall started: Nov. 21, 2004
Device type: Staple, Implantable
Root cause (FDA): Other
What the company told customers: The firm sent letters, dated 11/21/04, to all consignees.
Recall number: Z-0462-05

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0457-05, Z-0458-05, Z-0459-05, Z-0460-05, Z-0461-05, Z-0462-05. The agency record governs; check it and the company before acting.

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