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Terminated

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.

FDA Recall Z-2428-2015 · Posted 2015-08-20

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJDB
Date Initiated2015-06-24
Date Terminated2016-04-29
Product Quantity16992 total

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.

Firm 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.

Root Cause

Packaging change control

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070236SBI LATERAL RADIO CAPITELLUMSmall Bone Innovations, Inc. · 2007-02-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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