Recall Z-2427-2015— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2427-2015
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: K061146. Product: uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.. 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

K061146 — SBI ULNAR HEAD IMPLANTSmall Bone Innovations, Inc.·cleared 2006-07-19

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

uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.

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.