Sigmoid Notch recall: Sterility Concern
Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head…
Why was Sigmoid Notch 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended for replacement of the distal radio-ulnar joint following ulnar head…
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 16992 total
- Distribution
- Worldwide Distribution.
- Recall date
- August 26, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)