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Class 2 Device Recall Domed TriPeg Patella, 38x9mm, E |
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Date Initiated by Firm |
October 05, 2023 |
Date Posted |
January 02, 2024 |
Recall Status1 |
Completed |
Recall Number |
Z-0626-2024 |
Recall Event ID |
93623 |
510(K)Number |
K113756
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Product Classification |
shoulder prosthesis, reverse configuration - Product Code PHX
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Product |
REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 |
Code Information |
UDI: (01)00888912108560/Lot Number(s): 157N1556 |
Recalling Firm/ Manufacturer |
Encore Medical, LP 9800 Metric Blvd Austin TX 78758-5445
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For Additional Information Contact |
Julie Zorka 512-832-9500
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Manufacturer Reason for Recall |
Mislabeling
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FDA Determined Cause 2 |
Packaging process control |
Action |
On October 5, 2022, DJO Global (Enovis company) issued a "Urgent Medical Device Recall" Notification via E-Mail. DJO asked consignees to take the following actions:
1. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred.
2. Review your stock for the affected products and lot numbers for the items to be returned.
3. Complete acknowledgement and response form and contact Customer Service at 1-800-456-8696 to place a replacement order and receive an RMA number. You will be provided with a shipping label to return the affected product.
4. Return all affected devices (quantities listed above) using the RMA number.
Report any adverse events related to this issue to Customer Service. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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Quantity in Commerce |
2 units |
Distribution |
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
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Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = PHX and Original Applicant = ENCORE MEDICAL, L.P.
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