Reported Jul 3, 2024 · Ongoing

RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206

Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used
  • in hip hemi-arthroplasty Item Number11-165206
Lot codes and dates

4 of 4 products

Products covered by this recall
#BarcodesProduct as published
100880304001923Lot Number / UDI Number (1) 66540443 (01)00880304001923(17)290408(10)66540443
200880304001923(2) 66601057 (01)00880304001923(17)290405(10)66601057
300880304001923(3) 66623486 (01)00880304001923(17)290327(10)66623486
400880304001923(4) 66635486 (01)00880304001923(17)290327(10)66635486
Amount recalled
12 units

Where it was sold

Why it was recalled

41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.