CLASS II Device recall · Reported 18 Dec 2019 · FDA Enforcement Report
P28, Titan 3-D Wedge, Evans, Large, sterile recalled by Paragon 28
Paragon 28 is recalling P28, Titan 3-D Wedge, Evans, Large, sterile, distributed in 34 states. The recall was initiated on 28 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0662-2020
- FDA event ID
- 84234
- Recalling firm
- Paragon 28, Englewood, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Sep 2018
- FDA classified
- 10 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 28 Sep 2018 | Recall initiated by company | |
| 10 Dec 2019 | Classified by FDA | +438 days |
| 18 Dec 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
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
ArkansasCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMississippiMontanaNorth CarolinaNebraska
Questions about this recall
Is P28, Titan 3-D Wedge, Evans, Large, sterile recalled?
Yes. Paragon 28 recalled P28, Titan 3-D Wedge, Evans, Large, sterile on 28 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0662-2020.
Why was it recalled?
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.
Which lots are affected?
Lot # BR4108
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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