Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head resection arthroplasty.
This recall has been terminated (originally issued August 20, 2015).
- Recall Initiated
- June 24, 2015
- Posted
- August 20, 2015
- Terminated
- April 29, 2016
- Recall Number
- Z-2430-2015
- Quantity
- 16992 total
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution.
Lot / Code Info
Part Number: 390-0305 (Sigmoid Notch Radial Stem, Small) - Lot #'s 18362, 22834401 and 23852901; Part Number: 390-0307 (Sigmoid Notch Radial Stem, Large) - Lot #'s 18728, 18815, 18816, 18817, 23834501 and 23853001
Root Cause
Packaging change control
Action Taken
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.