Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. — recall Z-2145-2020

U.S. FDA — Device Enforcement · United States · 2020-04-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2145-2020
Date of alert: 2020-04-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Biomet, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00880304568785

Reported risk: Potential presence of elevated endotoxin levels that exceed the specification limit

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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