Biomet Recalls RingLoc Hip System Components Due to Endotoxin Levels
Biomet, Inc. is recalling specific RingLoc Hip System components due to potential elevated endotoxin levels that exceed specification limits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Biomet, Inc. is recalling specific RingLoc Hip System components, including acetabular bi-polar cups, acetabular cups, and acetabular liners, used in hemi hip arthroplasty. The recall involves 58 units of these medical devices.
The recall is being conducted because of the potential presence of elevated endotoxin levels that exceed the specification limit. Endotoxins are substances that can cause adverse health effects if introduced into the body.
The affected products were distributed worldwide, including in the United States, Canada, and various international locations. Consumers and healthcare providers should contact Biomet, Inc. for further instructions regarding the recall and replacement of these devices.
The recalled product
- Product
- 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…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 58
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 2) 094360 (01)00880304209688(17)220106(10)094360
- 3) 588500 (01)00880304209688(17)220106(10)094360
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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