Recalls / —
—#138753
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.
- FDA product code
- KXE — Prosthesis, Wrist, Hemi-, Ulnar
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K061146
- Affected 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
Why it was recalled
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.
Root cause (FDA determination)
Packaging change control
Action the firm took
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.
Recalling firm
- Firm
- Stryker Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2006
Distribution
- Distribution pattern
- Worldwide Distribution.
Timeline
- Recall initiated
- 2015-06-24
- Posted by FDA
- 2015-08-20
- Terminated
- 2016-04-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #138753. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.