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REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg… recallZ-0626-2024 · Encore Medical, LP · initiated Oct 5, 2023

Completed

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, LP or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Mislabeling

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-0626-2024
Status
Completed
Initiated by the company
Oct 5, 2023
Posted by the FDA
Jan 2, 2024
Recalling firm
Encore Medical, LP
Quantity
2 units
Product code
PHX
FDA submissions
K113756
Distribution
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.

Product description

REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2

Code information (models, lots, serial numbers)

UDI: (01)00888912108560/Lot Number(s): 157N1556

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

6 devices cleared under K113756 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93623).

Sources and updates

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