Z-2428-2015Class II

Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for...

Name: Z-2428-2015 Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated for use in the elbow for...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2015-06-24
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-06-24 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Radio-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... on 2015-06-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2428-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-08-20
Terminated: 2016-04-29
Recalling firm: Howmedica Osteonics Corp
Product: Radio-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.
Product code: JDB Prosthesis, Elbow, Semi-Constrained, Cemented
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.
Root cause tag: packaging
FDA root 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.
Product codes and lots: Part 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2428-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2426-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2427-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2428-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2429-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20
Z-2430-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-20

Product code JDB

K070236Class IISbi Lateral Radio CapitellumSmall Bone Innovations, Inc. / cleared 2007-02-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)