Recall Z-2428-2015— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2428-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-24

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2015-06-24, terminated 2016-04-29. It names one FDA 510(k) clearance: K070236. 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.. Reason: 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..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Terminated: 2016-04-29
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K070236 — SBI LATERAL RADIO CAPITELLUMSmall Bone Innovations, Inc.·cleared 2007-02-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.