Encore Medical, LP: Shoulder Implant Socket Inserts Recalled for Incorrect Sizing Information

Agency Publication Date: November 8, 2023

Summary

Encore Medical is recalling 40 units of RSP Humeral Socket Inserts because two different sizes of these orthopedic shoulder implant components were swapped during the packaging process. Specifically, Size 32 mm and Size 36 mm inserts were placed in the wrong boxes, which can lead to a surgeon having the incorrect device available during a procedure. This issue affects components sold in 13 states including California, Florida, and New York. Consumers should contact their healthcare provider or the manufacturer for guidance regarding these implants.

Risk

If a surgeon receives a mismatched device in the operating room, it can cause a significant delay in surgery while the correct part is located and prepared. This delay increases the time a patient is under anesthesia and could lead to complications during the surgical procedure.

What You Should Do

Identify if you or your surgical facility has the RSP Humeral Small Socket Insert Size 32 mm (REF: 509-03-432) with UDI-DI 00190446257585 and Lot number 954W1194.
Check for the RSP Humeral Socket Insert Size 36mm (REF: 509-01-436) with UDI-DI 00888912144667 and Lot number 390P1157.
Contact your healthcare provider or surgical coordinator immediately to determine if an affected device was used in your procedure or is currently in inventory.
Contact the manufacturer, Encore Medical, LP, at their Austin, Texas headquarters by calling 512-832-9500 for further instructions regarding the return or exchange of affected units.
For additional information or questions, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification and Medical Consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus

Model / REF:

509-03-432

UPC Codes:

00190446257585

Lot Numbers:

954W1194

Product: RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm

Model / REF:

509-01-436

UPC Codes:

00888912144667

Lot Numbers:

390P1157

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93221

Status: Active

Manufacturer: Encore Medical, LP

Sold By: hospitals; surgical centers; medical distributors

Manufactured In: United States

Units Affected: 2 products (20)

Distributed To: Minnesota, Texas, Indiana, Ohio, South Carolina, Rhode Island, Maine, New Jersey, New York, Kansas, Louisiana, Florida, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you or your surgical facility has the RSP Humeral Small Socket Insert Size 32 mm (REF: 509-03-432) with UDI-DI 00190446257585 and Lot number 954W1194.

Check for the RSP Humeral Socket Insert Size 36mm (REF: 509-01-436) with UDI-DI 00888912144667 and Lot number 390P1157.

Contact your healthcare provider or surgical coordinator immediately to determine if an affected device was used in your procedure or is currently in inventory.

Contact the manufacturer, Encore Medical, LP, at their Austin, Texas headquarters by calling 512-832-9500 for further instructions regarding the return or exchange of affected units.

For additional information or questions, contact the FDA's medical device recall line at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.