Z-0662-2020 Class II Terminated
FDA device recall Z-0662-2020 was initiated by Paragon 28, Inc. on September 28, 2018 and is designated Class II. Reason for recall: It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could res… The recall status is terminated (terminated August 20, 2020). Affected quantity: 64 Wedge Systems.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- September 28, 2018
- Termination Date
- August 20, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 Wedge Systems
Product Description
P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only
Reason for Recall
It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of the product could result in improper preparation of the surgical site causing delays in surgery.
Distribution Pattern
AR, CA, CO, CT, DC, DE,FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MT, MS, NC, NE, NY, NJ, NV, OH, OR, PA, SC, SD, TN, TX, VT, WA, WI, WY OUS: Australia & Israel
Code Information
Lot # BR4108