Recall Z-0662-2020— Paragon 28, Inc.
Class II · Terminated
Class II FDA medical device recall by Paragon 28, Inc., initiated 2018-09-28, terminated 2020-08-20. It names one FDA 510(k) clearance: K162241. 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. Reason: 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..
- Recalling firm
- Paragon 28, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-28
- Terminated
- 2020-08-20
- Firm location
- Englewood, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.