HIGH

Theken Companies Recalls Bipolar Hip Implants Over Sterility Issue

Theken Companies recalled 409 Bipolar Hip Implants on September 11, 2025. The devices failed transit testing and may have compromised sterile barriers. Patients and healthcare providers must stop using the implants immediately.

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
Theken Companies
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Theken Companies LLC or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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Product Details

The recall includes Bipolar Head Assemblies in sizes ranging from 38mm to 60mm. The affected models include part IDs 10-22-0038 through 10-22-0060. The implants were distributed nationwide in New Jersey, Pennsylvania, and Texas.

The Hazard

The implants may have potential issues with their sterile barrier due to failed transit testing. This can lead to serious infections or complications if the device is used.

Reported Incidents

No specific incidents or injuries have been reported to date. The recall is classified as Class II, indicating a high risk but no reported deaths.

What to Do

Stop using the recalled implants immediately. Follow instructions provided by Theken Companies LLC or your healthcare provider. Contact them for further details regarding the recall.

Contact Information

For more information, contact Theken Companies LLC at the provided contact information on their website. Visit the FDA link for further details on the recall.

Key Facts

  • 409 Bipolar Hip Implants recalled
  • Sizes range from 38mm to 60mm
  • Potential sterility issues identified
  • Patients must stop using devices immediately
  • Contact manufacturer for instructions

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
10-22-0038 UDI-DI 00816127029431 Lots 2036
2036-RP
3495
3495-1
10-22-0040 UDI-DI 00816127029448 Lots 2037
+15 more
Affected States
ALL
Report Date
October 29, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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