Encore Medical, LP: Shoulder and Knee Implants Recalled for Mislabeling

Agency Publication Date: January 2, 2024

Summary

Encore Medical is recalling 19 units of its surgical implants, including the Reverse Shoulder System RSP Humeral Socket Insert and the All-Poly e+ Patella (kneecap component), due to mislabeling. These medical devices are used in orthopedic surgeries, and incorrect labels can lead to the wrong component size or type being selected during a procedure. The recall affects 17 shoulder inserts and 2 patella components distributed in several states, including California, Texas, and Florida.

Risk

Mislabeled implants can lead to surgical errors where an incorrect part is used, potentially causing joint instability, premature wear of the implant, or the need for additional corrective surgery. No specific injuries have been reported in the provided data.

What You Should Do

Identify if you have the affected shoulder implant: Reverse Shoulder System e+, RSP Humeral Socket Insert, Size 32mm (REF 509-01-032) with Lot Number 381P1167 and UDI (01)00888912144612.
Identify if you have the affected knee implant: All-Poly e+ Patella, Domed Tri-Peg, 9x38mm (REF 130-03-738) with Lot Number 157N1556 and UDI (01)00888912108560.
If you are a patient who has received a shoulder or knee replacement and are concerned about these components, contact your orthopedic surgeon or healthcare provider to discuss your surgery records.
Healthcare facilities should check their inventory for these specific REF and Lot numbers and contact Encore Medical, LP at 9800 Metric Blvd, Austin, Texas for further instructions.
For additional information, you may contact the manufacturer or the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer notification and guidance

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

Affected Products

Product: Reverse Shoulder System e+, RSP Humeral Socket Insert (32mm)

Model / REF:

REF 509-01-032

UPC Codes:

00888912144612

Lot Numbers:

381P1167

Product: All-Poly e + Patella, Domed Tri-Peg (9x38mm)

Model / REF:

REF 130-03-738

UPC Codes:

00888912108560

Lot Numbers:

157N1556

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93623

Status: Resolved

Manufacturer: Encore Medical, LP

Sold By: Hospitals; Surgical Centers

Manufactured In: United States

Units Affected: 2 products (17 units; 2 units)

Distributed To: Virginia, Tennessee, Minnesota, Indiana, Rhode Island, Maine, Texas, Louisiana, Alabama, 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 have the affected shoulder implant: Reverse Shoulder System e+, RSP Humeral Socket Insert, Size 32mm (REF 509-01-032) with Lot Number 381P1167 and UDI (01)00888912144612.

Identify if you have the affected knee implant: All-Poly e+ Patella, Domed Tri-Peg, 9x38mm (REF 130-03-738) with Lot Number 157N1556 and UDI (01)00888912108560.

If you are a patient who has received a shoulder or knee replacement and are concerned about these components, contact your orthopedic surgeon or healthcare provider to discuss your surgery records.

Healthcare facilities should check their inventory for these specific REF and Lot numbers and contact Encore Medical, LP at 9800 Metric Blvd, Austin, Texas for further instructions.

For additional information, you may contact the manufacturer or the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.