Class 2 Device Recall Stryker rHead Lateral Stem

• Date Initiated by Firm: June 24, 2015
• Date Posted: August 20, 2015
• Recall Status: Terminated on April 29, 2016
• Recall Number: Z-2426-2015
• Recall Event ID: 71676
• 510(K)Number: K102180
• Product Classification: Prosthesis, elbow, semi-constrained, cemented - Product Code JDB
• Product: rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
• Code Information: 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
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Mr. Paul Jahnke; 201-831-5826
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Packaging change control
• 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.
• Quantity in Commerce: 16992 total
• Distribution: Worldwide Distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JDB and Original Applicant = SMALL BONE INNOVATIONS, INC.