| Class 2 Device Recall EMPOWR 3D Kneetm INS | |
Date Initiated by Firm | May 05, 2022 |
Create Date | June 09, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1257-2022 |
Recall Event ID |
90230 |
510(K)Number | K143242 |
Product Classification |
Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
|
Product | DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 |
Code Information |
Lot number 078T1141 |
Recalling Firm/ Manufacturer |
Encore Medical, LP 9800 Metric Blvd Austin TX 78758-5445
|
For Additional Information Contact | 512-834-6200 |
Manufacturer Reason for Recall | A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | On 05/05/2022, recall notices were emailed to DJO Surgical Agents by Enovis. Notices state that DJO Surgical requires the following actions:
1) Pass on the recall notice within your organization or to any organization where the potentially affected product has been transferred.
2) Contact Customer Service at 1-800-456-8696 to place a replacement order and to receive an RMA number to return affected devices.
3) Customers with questions or issues can contact Customer Service.
|
Quantity in Commerce | 20 |
Distribution | U.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.
|
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = JWH
|
|
|
|