Reported Aug 26, 2015 · Terminated
rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
Stryker Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
- Lot codes and dates
40 of 40 products
Products covered by this recall Model / number Barcodes Product as published 310-0001Lot #'s 22288301, 22890701, 23424401, 23916901, 19058-S2, 19452-S2, 19661-S2, 19662-S2, 19712-S2, 19736-S2 and 19841-S2; (Lateral Assembly, Radial Implant, Size 310-0002Lot #'s 22629201, 22890801, 23424501, 23917001, 19453-S2, 19737-S2, 19765-S2, 19766-S2 and 19793-S2; (Lateral Assembly, Radial Stem Implant, Size 310-0003Lot #'s 22288401, 22629301, 23198901, 23434601, 23917101, 19678-S2, 19767-S2, 19768-S2, 19794-S2 and 19842-S2; (Lateral Assembly, Radial Implant, Size 310-0005Lot #'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; (Lat Assembly, Rad Stem Implant, Collar 6mm, Size 310-0006Lot #'s 23424901, 23917301, 19063-S2, 19124-S2, 19455-S2, 19714-S2, 19740-S2 and 19797-S2; (Lat Assembly, Rad Stem Implant, Collar 6mm, size 310-0007Lot #'s 23199101, 23425001, 19059-S2, 19680-S2, 19741-S2, 19798-S2 and 19845-S2; (Lat Assembly, Rad Stem Implant, Collar 6mm, size 310-0008Lot #"s 22890901, 2345101, 19060-S2, 19125-S2 and 19457-S2; (Lateral Assembly, Radial Head Implant, Size — Lot #'s 22288701, 22629401, 22891001, 23199201, 23425201 and 23917401; Part Number:(Lateral Assembly, Radial Head Implant, Size 310-0010Lot #'s 15886, 22288801, 22629501, 22891101, 23199301, 23425301, 23917501 and 23917502; (Lat Assembly, Rad Stem Head Implant, Size 310-0011Lot #'s 15887, 23199401, 23425401, 23917601 and 19458-S2; (Lateral Assembly, Radial Head Impl Assembly, Size 310-0012Lot #'s 16708, 16709, 22629601, 22891201 and 23425501; (Lateral Assembly, Radial Head Impl Assembly, Size 310-0013Lot #'s 16710, 16711, 22629701, 22891301 and 23425601; (Lateral Assembly, Radial Head Impl Assembly, Size 310-2011Lot #'s 16712 and 23425701; Part Number: 310-2010 (rHead Stem Implant Plasma Coated, Size1) Lot #'s 22552401, 19693-S2, 19742-S2 and 19799-S2; (rHead Stem Implant Plasma Coated, Size 310-2012Lot #'s 22552501, 19694-S2 and 19743-S2; (rHead Stem Implant Plasma Coated, Size 310-2013Lot #'s 22552601, 19070-S2, 19695-S2, 19744-S2 and 19800-S2; (rHead Stem Implant Plasma Coated, Size 310-2014Lot #'s 22552701, 19696-S2 and 19745-S2; (rHead Stem Implant 6mm Collar, Size 310-2015Lot #'s 22552801, 22552802, 19697-S2, 19698-S2 and 19746-S2; (rHead Stem Implant 6mm Collar, Size 310-2016Lot #'s 22552901, 19699-S2, 19747-S2 and 19915-S2; (rHead Stem Implant 6mm Collar, Size 310-2017Lot #'s 22553001, 19700-S2 and 19748-S2; (rHead Stem Implant 6mm Collar, Size 310-2018Lot #22553101; (rHead Recon Stem Implant Plasma Coated, Size - Amount recalled
- 16992 total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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