Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-1246-2018

Z-1246-2018 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
April 4, 2018
Initiation Date
November 9, 2017
Termination Date
April 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5988

Product Description

1. InterPulse Handpiece with coaxial bone cleaning tip, Product Number: 0210-110-100, UDI: (01)4546540861641; 2. InterPulse Handpiece with Coaxial High Flow Tip, Product Number: 0210-114-100, UDI: (01)4546540861764; 3. InterPulse Handpiece with Retractable Coaxial Fan Spray Tip, Product Number: 0210-118-200, UDI: (01)4546540861818; 4. InterPulse Irrigation Only Handpiece with Fan Spray Tip, Product Number: 0210-218-000, UDI: (01)4546540144300 for orthopedic use.

Reason for Recall

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Distribution Pattern

Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

Code Information

1. Lot Numbers: 17283012, 17284012, 17286012; 2. Lot Numbers: 17278012, 17280012, 17282012, 17283012, 17285012, 17289012, 17292012; 3. Lot Number: 17279012; 4. Lot Number: 17284012 UDI: (01)4546540861641; (01)4546540861764; (01)4546540861818; (01)4546540144300

Other recalls by Stryker Instruments Div. of Stryker Corporation

  • Z-1452-2022 Class II — SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002 (June 15, 2022)
  • Z-0431-2021 Class II — Stryker Zyphr Disposable Cranial Perforator, Large 14/11 mm- is a sterile, singl (October 16, 2020)
  • Z-1807-2020 Class II — Neptune E-SEP 165mm Blade Electrode, Catalog Number 0703-165-001 - Product Usage (March 26, 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-1099-2020 Class II — Telescopic Uncoated (Push Button), Product No. SHK TSPL. The product is a Bovie (January 13, 2020)
  • Z-1097-2020 Class II — SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The produ (January 13, 2020)
  • Z-0593-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0592-2020 Class II — Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), (November 6, 2019)
  • Z-0024-2020 Class II — C2 Nerve Monitor, 8 Channel, 5140-508-280, UDI 07613327277319 Product Usage: (July 31, 2019)