Device product
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.
Z-2430-2015
Product summary
- Event
- Event 71676
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16992 total
- Official record key
device-enforcement:Z-2430-2015
Official wording
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.
Code information: 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
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Sterility assurance
sterile barrier) of the packaging type KIT I may potentially be compromised