Z-0662-2020Class II

P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01)...

Name: Z-0662-2020 P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01)...
Creator: Paragon 28, Inc.
Published: 2018-09-28
License: https://open.fda.gov/license/

Paragon 28 / initiated 2018-09-28 / Terminated / root cause: labeling and UDI

FDA source

Paragon 28, Inc. began a recall of 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 on 2018-09-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0662-2020
Classification: Class II
Status: Terminated
Initiated: 2018-09-28
Posted: 2019-12-10
Terminated: 2020-08-20
Recalling firm: Paragon 28
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
Product code: PLF Bone Wedge
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.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
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
Quantity in commerce: 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
Product codes and lots: Lot # BR4108

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0662-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0662-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-10

Product code PLF

K162241Class IITITAN 3-D™ Wedge SystemParagon 28 / cleared 2017-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)