Z-2096-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2017
- Initiation Date
- March 30, 2017
- Termination Date
- August 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 360 units total
Product Description
AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrectomy Cutter and Irrigation Sleeve (Model Number NGP0020) Used with the AMO Whitestar Signature System. For ophthalmic use.
Reason for Recall
Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.
Distribution Pattern
Worldwide distribution to SA, TR, AZ, NL, PT, SG, AU, JP, and HK.
Code Information
Part Number NGP0025 Lot CA06182 (72 units) Part Number NGP0020 Lot CA06180 (288 units)