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Z-1807-2020 Class II Terminated

Recalled by Stryker Instruments Div. of Stryker Corporation — Portage, MI

FDA device recall Z-1807-2020 was initiated by Stryker Instruments Div. of Stryker Corporation on March 26, 2020 and is designated Class II. Reason for recall: Due to a distribution error, product from the affected lot was shipped expired. The recall status is terminated (terminated July 15, 2020). Affected quantity: 40 units.

Recall Details

Product Type
Devices
Report Date
May 6, 2020
Initiation Date
March 26, 2020
Termination Date
July 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 units

Product Description

Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage: The Neptune E-SEP is an Integrated Smoke Evacuation Pencil (pencil) designed for general electrosurgical applications including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

Reason for Recall

Due to a distribution error, product from the affected lot was shipped expired.

Distribution Pattern

International distribution the country of Canada.

Code Information

Lot 16240231, GTIN 07613327297799

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  • Z-0431-2021 Class II — Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, singl (October 16, 2020)
  • Z-1402-2022 Class II — Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG (January 22, 2020)
  • Z-1098-2020 Class II — Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. The product is (January 13, 2020)
  • Z-1097-2020 Class II — SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The produ (January 13, 2020)
  • Z-1099-2020 Class II — Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie (January 13, 2020)
  • Z-0592-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0593-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0023-2020 Class II — C2 Nerve Monitor, 4 Channel, 5140-508-240, UDI 07613327177329 Product Usage: (July 31, 2019)
  • Z-0024-2020 Class II — C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: (July 31, 2019)

FDA data resources