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DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral… recallZ-2606-2023 · Encore Medical, LP · initiated Aug 4, 2023

Open, Classified

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

Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

FDA root cause category: Nonconforming Material/Component

What the company is doing

On 8/4/23, recall notices were mailed to surgeons and distributors. They were reminded that starting on 7/3/23 they were contacted by the firm, and asked to quarantine affected devices, and that the affected devices had since been retrieved by the firm's sales representatives. Surgeons were asked to take the following actions: 1) We ask that you reach out to your patient[s] who were implanted with affected components as identified above and consider whether it may be appropriate for your patient to be monitored more closely to watch for signs and symptoms of acute or chronic infection. 2) We have also provided a patient letter for you to provide to your patient[s] who was [were] implanted with an affected component[s] should you prefer a written notification to accompany your verbal contact. 3) Please make the hospital where you implanted the components aware of this action, as appropriate by providing a copy of this communication or verbally notifying the hospital. 4) Please review and complete the enclosed Voluntary Recall Response Form. If you have any questions phone the firm at 1(800)456-8696 between the hours of 7:30AM-6:00PM CST, or e-mail [email protected] In addition, distributors were asked to do the following: Provide the notification to any additional organizations or members within your facility or network where devices subject to this voluntary recall may have been transferred.

Recall details

Recall number
Z-2606-2023
Status
Open, Classified
Initiated by the company
Aug 4, 2023
Posted by the FDA
Sep 19, 2023
Recalling firm
Encore Medical, LP
Quantity
64
Product code
PHX
FDA submissions
K051075
Distribution
US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany

Product description

DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm, REF: 508-01-032; Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm, REF: 508-32-104; Reverse Shoulder System (RSP) Glenoid, Neutral Head W/ Retaining Screw, 36mm, REF: 508-36-101

Code information (models, lots, serial numbers)

REF/UDI-DI/Lot/Expiration: 508-01-032/00888912024693/859C1190/April 29, 2027; 508-32-104/00888912024754/866C3153/May 25, 2029 and 866C3147/April 3, 2029; 508-36-101/869C3539/April 30, 2028

Devices named in this recall

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

Other devices under the same FDA submission

26 devices cleared under K051075 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 92969).

Sources and updates

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