Tuesday, August 25, 2015

News: Stryker initiated a Class II recall of 16,992 units of elbow replacement devices due to potential compromise of packaging integrity

Class 2 Recall - Stryker RadioCapitellum, Capitellum

Date PostedAugust 20, 2015
Recall Status1Open
Recall NumberZ-2428-2015
Recall Event ID71676
Product Classification Prosthesis, Elbow, Semi-Constrained, Cemented - Product Code JDB
ProductRadio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients.
Code InformationPart Number: 410-0000 (Radio Capitellum Large, Left) - Lot #'s 18832, 22193201, 22193202, 22193203, 22258301,22957101, 23853901, 19069-S2, 19077-S2 and 19155S2; Part Number: 410-0001 (Radio Capitellum Small, Left) - Lot #'s18833, 18834, 22193302, 22193303, 22766801, 2295601 and 23853101; Part Number: 410-0002 (Radio Capitellum Large, Right) - Lot #'s18835, 18836, 22193401, 22193402, 22193403, 22766901, 22956301, 23853201 and 19074-S2; Part Number: 410-0003 (Radio Capitellum Small, Right) - Lot #'s 18565, 22193501, 22193502, 22193503, 22767001, 22956401 and 23853301
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2006
For Additional Information ContactMr. Paul Jahnke
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.
ActionBranches/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 Commerce16992 total
DistributionWorldwide Distribution.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55 Published at FDA & OrthoWorld 

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