Zimmer Biomet, Inc.: RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223

Is my product affected?

RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223

• UPC 00880304651524
• UPC 00880304651494

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

What happened

Zimmer Biomet, Inc. is recalling RingLoc ArComXL Highly Crosslinked Polyethylene Liners in two sizes (Size 23 items XL-108323 and XL-108223) due to a labeling discrepancy. The part and lot numbers printed on the packaging did not match the actual product contained inside the packages, which could potentially delay surgical procedures. The recall affects 36 units that were distributed nationwide in the USA and internationally to Argentina.

The recall involves two specific lots: Item XL-108323 Lot 761680 and Item XL-108223 Lot 419460. The source document does not specify what actions affected consumers should take in response to this recall.

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

Hazard

Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.

Details from the source

Reason for recall: Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery. Distribution: USA (nationwide) and Internationally to ARGENTINA Quantity: 36 Lot/code info: Item XL-108323 Lot 761680 UDI (01)00880304651524(17)210713(10)761680 Item XL-108223 Lot 419460 UDI (01)00880304651494(17)210713(10)419460

Source

Official record: FDA (Device enforcement) ↗

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

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