Recall Z-0662-2020
Paragon 28, Inc. · initiated September 28, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot # BR4108
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.
FDA-determined cause: Error in labeling
Action taken
On September 19th, 2018 Paragon 28 issued a Recall Letter to consignees via email and physical mail. The letter informed consignees of the product mislabeling issue. They were instructed to immediately take the following actions: 1. Review inventory of the TITAN 3D Wedge implants to determine if they possess affected product. 2. If they possess the affected product, return product to Paragon 28 for disposition 3. Regardless, if they have or do not have affected recall product, complete and return an acknowledgement form to Paragon 28
Details
- Recall number
- Z-0662-2020
- Initiated
- September 28, 2018
- Posted by FDA
- December 10, 2019
- Terminated
- August 20, 2020
- Product code
- PLF – Bone Wedge
- Quantity
- 64 Wedge Systems
- Distribution
- 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
- Recalling firm
- Paragon 28, Inc., Englewood, CO