| | Class 2 Device Recall P28, Titan 3D Wedge |  |
| Date Initiated by Firm | September 28, 2018 |
|---|
| Date Posted | December 10, 2019 |
|---|
| Recall Status1 |
Terminated 3 on August 20, 2020 |
| Recall Number | Z-0662-2020 |
|---|
| Recall Event ID |
84234 |
| 510(K)Number | K162241 |
|---|
| Product Classification |
Bone Wedge - Product Code PLF
|
| 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 |
|---|
| Code Information |
Lot # BR4108 |
| FEI Number |
3008650117
|
Recalling Firm/
Manufacturer |
Paragon 28, Inc.
4B Inverness Ct E Ste 280
Englewood
CO
80112-5329
|
| For Additional Information Contact | Eric Lintula
888-728-1888 |
|---|
Manufacturer 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 2 | 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 |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = PLF
|
|---|
|
|
|
