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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Encore Medical, LP: Orthopedic Implants Recalled Due to Lack of Final Sterilization

Agency Publication Date: September 19, 2023
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Summary

Encore Medical (DJO Surgical) is recalling 109 units of various orthopedic implant components, including knee, hip, and shoulder replacement parts, because they were shipped without undergoing final sterilization. These unsterilized devices were distributed across 26 U.S. states and several international locations. If these components are implanted, they can cause serious infections that may require medical treatment, long-term monitoring, or additional revision surgery to replace the device.

Risk

The affected orthopedic components were not properly sterilized before shipment, posing a direct risk of bacterial infection if used in surgery. This could lead to severe internal infections at the surgical site, potentially requiring complex follow-up operations to remove or replace the contaminated hardware.

What You Should Do

  1. Identify if you have received one of the following affected DJO Surgical components: Empowr Knee Tibia Baseplate (Lot 308V1112), Delta Ceramic Femoral Head (Lot 878B1171), CLP Hip Stem (Lot 415N1014), RSP Shoulder System inserts or baseplates (Lots 859C1190, 866C3153, 866C3147, 869C3539), or Altivate Reverse Humeral Stem (Lot 923W1411).
  2. Check the specific expiration dates on the packaging, which range from May 2, 2027, to May 25, 2029.
  3. If you are a healthcare provider or facility, immediately stop using the affected lot numbers and quarantine any remaining stock.
  4. If you have recently undergone a knee, hip, or shoulder replacement and are concerned about these specific components, contact your orthopedic surgeon or healthcare provider immediately to discuss your implant details and any necessary monitoring for infection.
  5. Contact the manufacturer, Encore Medical (DJO Surgical), at their Austin, Texas headquarters or through their official website for instructions on returning unsterilized products and obtaining potential refunds or replacements.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer

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

Affected Products

Product: DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R
Model / REF:
REF: 352-02-106
Lot Numbers:
308V1112
Date Ranges: May 25, 2029
Product: DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm
Model / REF:
REF: 400-03-443
Lot Numbers:
878B1171
Date Ranges: May 2, 2027
Product: DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3
Model / REF:
REF: 426-11-030
Lot Numbers:
415N1014
Date Ranges: May 3, 2028
Product: DJO Surgical: RSP Semi Humeral Socket Insert, 32mm
Model / REF:
REF: 508-01-032
Lot Numbers:
859C1190
Date Ranges: April 29, 2027
Product: DJO Surgical: Baseplate, Glenoid HA-Coat, RSP, 6.5mm X 30mm
Model / REF:
REF: 508-32-104
Lot Numbers:
866C3153
866C3147
Date Ranges: May 25, 2029, April 3, 2029
Product: DJO Surgical: RSP Glenoid, Neutral Head W/ Retaining Screw, 36mm
Model / REF:
REF: 508-36-101
Lot Numbers:
869C3539
Date Ranges: April 30, 2028
Product: DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm
Model / REF:
REF: 533-06-108
Lot Numbers:
923W1411
Date Ranges: April 3, 2029

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92969
Status: Active
Manufacturer: Encore Medical, LP
Sold By: Hospitals; Surgical centers; Orthopedic clinics
Manufactured In: United States
Units Affected: 5 products (20; 10; 0; 64; 15)
Distributed To: Alabama, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Texas, Utah, Virginia, Washington

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 ยท 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.