Home / Recalls / Stryker Neurovascular / Z-0229-2020

Z-0229-2020 Class II Terminated

Recalled by Stryker Neurovascular — Fremont, CA

FDA device recall Z-0229-2020 was initiated by Stryker Neurovascular on Jun 8, 2018 and is designated Class II. Reason for recall: The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is… The recall status is terminated (terminated Apr 28, 2021). Affected quantity: 21971.

Recall Details

Product Type: Devices
Report Date: Nov 6, 2019
Initiation Date: Jun 8, 2018
Termination Date: Apr 28, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21971

Product Description

Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including neurovascular and peripheral vasculatures.

Reason for Recall

The product labels (pouch and carton) for products contain an incorrect value in millimeters (0.036mm) for the Guidewire Outer Diameter dimension. The inches dimension (0.014in) on the label is correct. The correct values are 0.014in (0.36mm). 0.036mm represents a typographical error.

Distribution Pattern

Worldwide distributions- U.S. Nationwide including the states of AL, AZ, AR, CA, CO, CT, DC, DE, FL, GA, GU, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY. Countries of Austria, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, and UK.

Code Information

UPN: M00326410 Lot Numbers/UDI:0000000564/ (01)04546540688767(17)201031(10) 0000000564; 0000000565/ (01)04546540688767(17)201031(10)0000000565; 0000000566/(01)04546540688767(17)201031(10)0000000566; 0000000673/ (01)04546540688767(17)201031(10)0000000673; 0000000674/ (01)04546540688767(17)201031(10)0000000674; 0000000675/ (01)04546540688767(17)201031(10)0000000675; 0000000983/ (01)04546540688767(17)201031(10)0000000983; 0000000982/ (01)04546540688767(17)201031(10)0000000982; 0000001016/ (01)04546540688767(17)201031(10)0000001016; 0000001017/ (01)04546540688767(17)201031(10)0000001017; 0000001018/ (01)04546540688767(17)201031(10)0000001018; 0000001280/ (01)04546540688767(17)201031(10)0000001280; 0000001279/ (01)04546540688767(17)201031(10)0000001279; 0000001278/ (01)04546540688767(17)201031(10)0000001278; 0000001289/ (01)04546540688767(17)201031(10)0000001289; 0000001290/ (01)04546540688767(17)201031(10)0000001290; 0000001291/ (01)04546540688767(17)201031(10)0000001291; 0000001495/ (01)04546540688767(17)201031(10)0000001495; 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0000002428/ (01)04546540688767(17)201231(10)0000002428; 0000002429/ (01)04546540688767(17)201231(10)0000002429; 0000002430/ (01)04546540688767(17)201231(10)0000002430; 0000002642/ (01)04546540688767(17)201231(10)0000002642; 0000002641/ (01)04546540688767(17)201231(10)0000002641; 0000002643/ (01)04546540688767(17)201231(10)0000002643; 0000002644/ (01)04546540688767(17)201231(10)0000002644; 0000002766/ (01)04546540688767(17)201231(10)0000002766; 0000002767/ (01)04546540688767(17)201231(10)0000002767; 0000002768/ (01)04546540688767(17)201231(10)0000002768; 0000002974/ (01)04546540688767(17)201231(10)0000002974; 0000002975/ (01)04546540688767(17)201231(10)0000002975; 0000002976/ (01)04546540688767(17)201231(10)0000002976; 0000003768/ (01)04546540688767(17)210131(10)0000003768; 0000003767/ (01)04546540688767(17)210131(10)0000003767; 0000003769/ (01)04546540688767(17)210131(10)0000003769; 0000003770/ (01)04546540688767(17)210131(10)0000003770; 0000003950/ (01)04546540688767(17)210131(10)0000003950; 0000004126/ (01)04546540688767(17)210131(10)0000004126; 0000004125/ (01)04546540688767(17)210131(10)0000004125; 0000004111/ (01)04546540688767(17)200124(10)0000004111; 0000004321/ (01)04546540688767(17)200130(10)0000004321; 0000004597/ (01)04546540688767(17)200205(10)0000004597; 0000004899/ (01)04546540688767(17)210228(10)0000004899; 0000004900/ (01)04546540688767(17)210228(10)0000004900; 0000004901/ (01)04546540688767(17)210228(10)0000004901; 0000005142/ (01)04546540688767(17)210228(10)0000005142; 0000005144/ (01)04546540688767(17)210228(10)0000005144; 0000005145/ (01)04546540688767(17)210228(10)0000005145; 0000005146/ (01)04546540688767(17)210228(10)0000005146; 0000005148/ (01)04546540688767(17)210228(10)0000005148; 0000005344/ (01)04546540688767(17)210228(10)0000005344; 0000005346/ (01)04546540688767(17)210228(10)0000005346; 0000005345/ (01)04546540688767(17)210228(10)0000005345; 0000005347/ (01)04546540688767(17)210228(10)0000005347; 0000005348/ (01)04546540688767(17)210228(10)0000005348; 0000005532/ (01)04546540688767(17)210331(10)0000005532; 0000005533/ (01)04546540688767(17)210331(10)0000005533; 0000005531/ (01)04546540688767(17)200301(10)0000005531; 0000005687/ (01)04546540688767(17)200305(10)0000005687; 0000005828/ (01)04546540688767(17)200307(10)0000005828; 0000004902/ (01)04546540688767(17)210228(10)0000004902; 0000004903/ (01)04546540688767(17)210228(10)0000004903; 0000005852/ (01)04546540688767(17)210331(10)0000005852; 0000005853/ (01)04546540688767(17)210331(10)0000005853; 0000005987/ (01)04546540688767(17)210331(10)0000005987; 0000005988/ (01)04546540688767(17)210331(10)0000005988; 0000005989/ (01)04546540688767(17)210331(10)0000005989; 0000006199/ (01)04546540688767(17)210331(10)0000006199; 0000006200/ (01)04546540688767(17)210331(10)0000006200; 0000006316/ (01)04546540688767(17)210331(10)0000006316; 0000006315/ (01)04546540688767(17)210331(10)0000006315; 0000006314/ (01)04546540688767(17)210331(10)0000006314; 0000006601/ (01)04546540688767(17)210325(10)0000006601; 0000006672/ (01)04546540688767(17)210326(10)0000006672; 0000006482/ (01)04546540688767(17)210331(10)0000006482; 0000006480/ (01)04546540688767(17)210331(10)0000006480; 0000006481/ (01)04546540688767(17)210331(10)0000006481; 0000006827/ (01)04546540688767(17)210401(10)0000006827; 0000006619/ (01)04546540688767(17)210331(10)0000006619; 0000006618/ (01)04546540688767(17)210331(10)0000006618; 0000006620/ (01)04546540688767(17)210331(10)0000006620; 0000007032/ (01)04546540688767(17)210407(10)0000007032; 0000007001/ (01)04546540688767(17)210430(10)0000007001; 0000006999/ (01)04546540688767(17)210430(10)0000006999; 0000007000/ (01)04546540688767(17)210430(10)0000007000; 0000007174/ (01)04546540688767(17)210410(10)0000007174; 0000007082/ (01)04546540688767(17)210408(10)0000007082; 0000007089/ (01)04546540688767(17)210430(10)0000007089; 0000007090/ (01)04546540688767(17)210430(10)0000007090; 0000007091/ (01)04546540688767(17)210430(10)0000007091; 0000007092/ (01)04546540688767(17)210410(10)0000007092; 0000007315/ (01)04546540688767(17)210430(10)0000007315; 0000007317/ (01)04546540688767(17)210430(10)0000007317; 0000007316/ (01)04546540688767(17)210430(10)0000007316; 0000007426/ (01)04546540688767(17)210430(10)0000007426; 0000007425/ (01)04546540688767(17)210430(10)0000007425; 0000007741/ (01)04546540688767(17)210422(10)0000007741; 0000007771/ (01)04546540688767(17)210423(10)0000007771; 0000007772/ (01)04546540688767(17)210423(10)0000007772; 0000009017.

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0229-2020
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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