Events

Recall of Device Recall Stryker rHead Lateral Stem

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71676
  • Event Risk Class
    Class 2
  • Event Number
    Z-2426-2015
  • Event Initiated Date
    2015-06-24
  • Event Date Posted
    2015-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138723
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
  • Reason
    Stryker is recalling rhead, uhead, sigmoid notch, remotion, radio capitellum because packaging integrity (sterile barrier) of the packaging type kit i may potentially be compromised by transportation.
  • Action
    Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.

Device

Device Recall Stryker rHead Lateral Stem
  • Model / Serial
    Part Number: 310-0000 (Lateral Assembly, Radial Implant, Size 1) Lot #'s 22288301, 22890701, 23424401, 23916901, 19058-S2, 19452-S2, 19661-S2, 19662-S2, 19712-S2, 19736-S2 and 19841-S2; Part Number: 310-0001 (Lateral Assembly, Radial Implant, Size 2) Lot #'s 22629201, 22890801, 23424501, 23917001, 19453-S2, 19737-S2, 19765-S2, 19766-S2 and 19793-S2; Part Number:310-0002 (Lateral Assembly, Radial Stem Implant, Size 3) Lot #'s 22288401, 22629301, 23198901, 23434601, 23917101, 19678-S2, 19767-S2, 19768-S2, 19794-S2 and 19842-S2; Part Number: 310-0003 (Lateral Assembly, Radial Implant, Size 4) Lot #'s 22288501, 23199001, 23424701, 23917201, 19068-S2, 19679-S2, 19713-S2, 19738-S2, 19795-S2 and 19843-S2; Part Number: 310-0004 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size1) Lot #'s 22288601, 23424801, 19057-S2, 19067-S2, 19454-S2, 19739-S2, 19796-S2 and 19844-S2; Part Number: 310-0005 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2) Lot #'s 23424901, 23917301, 19063-S2, 19124-S2, 19455-S2, 19714-S2, 19740-S2 and 19797-S2; Part Number: 310-0006 (Lat Assembly, Rad Stem Implant, Collar 6mm, size 3) Lot #'s 23199101, 23425001, 19059-S2, 19680-S2, 19741-S2, 19798-S2 and 19845-S2; Part Number: 310-0007 (Lat Assembly, Rad Stem Implant, Collar 6mm, size 4) Lot #"s 22890901, 2345101, 19060-S2, 19125-S2 and 19457-S2; Part Number: 310-0008 (Lateral Assembly, Radial Head Implant, Size 2) Lot #'s 22288701, 22629401, 22891001, 23199201, 23425201 and 23917401; Part Number:(Lateral Assembly, Radial Head Implant, Size 3) Lot #'s 15886, 22288801, 22629501, 22891101, 23199301, 23425301, 23917501 and 23917502; Part Number: 310-0010 (Lat Assembly, Rad Stem Head Implant, Size 4) Lot #'s 15887, 23199401, 23425401, 23917601 and 19458-S2; Part Number: 310-0011 (Lateral Assembly, Radial Head Impl Assembly, Size 2) Lot #'s 16708, 16709, 22629601, 22891201 and 23425501; Part Number: 310-0012 (Lateral Assembly, Radial Head Impl Assembly, Size 3) Lot #'s 16710, 16711, 22629701, 22891301 and 23425601; Part Number: 310-0013 (Lateral Assembly, Radial Head Impl Assembly, Size 4) Lot #'s 16712 and 23425701; Part Number: 310-2010 (rHead Stem Implant Plasma Coated, Size1) Lot #'s 22552401, 19693-S2, 19742-S2 and 19799-S2; Part Number: 310-2011 (rHead Stem Implant Plasma Coated, Size 2) Lot #'s 22552501, 19694-S2 and 19743-S2; Part Number: 310-2012 (rHead Stem Implant Plasma Coated, Size 3) Lot #'s 22552601, 19070-S2, 19695-S2, 19744-S2 and 19800-S2; Part Number: 310-2013 (rHead Stem Implant Plasma Coated, Size 4) Lot #'s 22552701, 19696-S2 and 19745-S2; Part Number: 310-2014 (rHead Stem Implant 6mm Collar, Size 1) Lot #'s 22552801, 22552802, 19697-S2, 19698-S2 and 19746-S2; Part Number: 310-2015 (rHead Stem Implant 6mm Collar, Size 2) Lot #'s 22552901, 19699-S2, 19747-S2 and 19915-S2; Part Number: 310-2016 (rHead Stem Implant 6mm Collar, Size 3) Lot #'s 22553001, 19700-S2 and 19748-S2; Part Number: 310-2017 (rHead Stem Implant 6mm Collar, Size 4) Lot #22553101; Part Number: 310-2018 (rHead Recon Stem Implant Plasma Coated, Size 1) Lot #'s 22553201, 22889801, 19701-S2, 19749-S2 and 19801-S2; Part Number: 310-2019 (rHead Recon Stem Implant Plasma Coated, Size 2) Lot #'s 22553301, 22889901, 19702-S2, 19750-S2, 19916-S2 and 19975-S2; Part Number: 310-2020 (rHead Recon Stem Implant Plasma Coated, Size 3) Lot #'s 22553401, 22890001, 19703-S2, 19751-S2, 19802-S2 and 19976-S2; Part Number: 310-2021 (rhead Recon Stem Implant Plasma Coated, Size 4) Lot #'s 22553501, 22890101, 197076-S2, 19704-S2, 19752-S2, 19917-S2 and 19977-S2; Part Number: 310-2022 (rHead Recon Stem Implant 6mm Collar, Size 1) Lot #'s 22553601, 22890201, 197501-S2 and 19753-S2; Part Number: 310-2023 (rHead Recon Stem Implant 6mm Collar, Size 2) Lot #'s 22553701, 22890301, 19706-S2 and 19754-S2; Part Number: 310-2024 (rHead Recon Stem Implant 6mm Collar, Size 3) Lot #'s 22553801, 22890401, 19075-S2, 19707-S2 and 19755-S2; Part Number: 310-2025 (rHead Recon Stem Implant 6mm Collar, Size 4) Lot #'s22553901, 22890501 and 19071-S2;  Part Number: 410-0100 (rHead Standard Extended Stem 6mm Collar, Size 1)  Lot #'s 18527, 18724, 19681-S2 and 19715-S2; Part Number: 410-0101 (rHead Standard Extended Stem 6mm Collar, Size 2) Lot #'s 18528, 18725, 19682-S2 and 19756-S2; Part Number: 410-0102 (rHead Standard Extended Stem 6mm Collar, Size 3) Lot #'s 18529, 18726, 19663-S2 and 19757-S2; Part Number: 410-0103 (rHead Standard Extended Stem 6mm Collar, Size 4) Lot #'s 18530, 18727, 19683-S2 and 19758-S2;  Part Number: RCN-S160 (rHead Recon Stem Implant Non-Coated, Size 1) Lot #'s 18370, 18371, 18388, 18569, 18698, 18718 22614101, 22849001, 23068201, 19102-S2, 19103-S2, 19104-S2, 19717-S2, 19804-S2 and 19920-S2; Part Number: RCN-S260 (rHead Recon Stem Implant Non-Coated, Size 2) Lot #'s 18372, 18373, 18699, 18719, 18840, 22614301, 22849201, 23068401, 19105-S2, 19106-S2, 19107-S2, 19773-S2, 19851-S2 and 19984-S2; Part Number: RCN-S360 (rHead Recon Stem Implant Non-Coated, Size 3) Lot #'s 18570, 18571, 18700, 18701, 18702, 18755, 18841, 1884222298301, 22298302, 22849401, 23479801, 19108-S2, 19723-S2, 19807-S2, 19854-S2, 19986-S2 and R23479801; Part Number: RCN-S460 (rHead Recon Stem Implant Non-Coated, Size 4) Lot #'s18572, 18703, 18704, 18756, 18843, 18844, 22298401, 22614601, 22849601, 19109-S2 and 19110-S2; Part Number: RHA-S160 (rhead Radial Implant 6mm Collar, Size 1) Lot #''s 18375, 18386, 18501, 18707, 18708, 18848, 18849, 18850, 18851, 18852, 22613101, 22850101, 23069101, 19113-S2, 19114-S2, 19115-S2, 19779-S2 and 19809-S2; Part Number: RHA-S260 (rhead Radial Implant 6mm Collar, Size 2) Lot #'s 18376, 18384, 18385, 18502, 18575, 18709, 18720, 18853, 18854, 22613301, 22850301, 23069301, 19116-S2, 19117-S2 and 19782-S2; Part Number: RHA-S360 (rhead Radial Implant 6mm Collar, Size 3) Lot #'s 18377,18383, 18503, 18710, 18711, 18856, 18857, 18858, 18859, 22613501, 22850501, 19118-S2, 19119-S2, 19730-S2 and 19813-S2; Part Number: RHA-S460 (rhead Radial Implant 6mm Collar, Size 4) Lot #'s 18379, 18382, 18504, 18576, 18712, 18713, 18860, 18861, 18862, 22613701, 22850701, 19120-S2 and 19121-S2
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA