Biomet, Inc.: Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588

Is my product affected?

Hip Products Item Number: 1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM 2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM 3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26 Product Usage: Hemi hip arthroplasty.

• UPC 00880304568785
• UPC 00880304209688

Check against the official notice below — it lists the full affected range.

What happened

Biomet, Inc. is recalling three hip products: the RingLoc Hip System Acetabular Bi-Polar Cup (28 MM X 51 MM), the RingLoc Bi-Polar Hip System Acetabular Cup (28 MM X 47 MM), and product number XL-105916 588. A total of 58 units have been affected by the potential presence of elevated endotoxin levels that exceed specification limits. These products were distributed worldwide, including throughout the United States and to Canada, India, Japan, Mexico, Singapore, Taiwan, Thailand, the Netherlands, and several other countries listed in the recall notice.

The specific lot numbers associated with this recall are identified by their UDI numbers in the recall record. Affected consumers can identify whether they have a recalled product by checking these lot and code numbers. The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential presence of elevated endotoxin levels that exceed the specification limit

Details from the source

Reason for recall: Potential presence of elevated endotoxin levels that exceed the specification limit Distribution: Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL. Quantity: 58 units Lot/code info: Lot Numbers: UDI Number 1) 752470 (01)00880304568785(17)220118(10)752470 854070 (01)00880304568785(17)220119(10)854070; 2) 094360 (01)00880304209688(17)220106(10)094360; 3) 588500 (01)00880304209688(17)220106(10)094360

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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