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
FDA Recall Z-0662-2020 · Posted 2019-12-10
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Recalling FirmParagon 28, Inc.
Recall StatusTerminated
Product CodePLF
Date Initiated2018-09-28
Date Terminated2020-08-20
Product Quantity64 Wedge Systems
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.
Firm Action
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
Root Cause
Error in labeling
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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