CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report
RingLoc ArComXL Highly Crosslinked Polyethylene Liners recalled
Zimmer Biomet is recalling RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall + Liners Size 23, distributed nationwide in the US. The recall was initiated on 19 Dec 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1024-2017
- FDA event ID
- 75970
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2016
- FDA classified
- 13 Jan 2017
- Reported
- 25 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 19 Dec 2016 | Recall initiated by company | |
| 13 Jan 2017 | Classified by FDA | +25 days |
| 25 Jan 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
USA (nationwide) and Internationally to ARGENTINA
Questions about this recall
Is RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall + Liners Size 23 recalled?
Yes. Zimmer Biomet recalled RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall + Liners Size 23 on 19 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1024-2017.
Why was it recalled?
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.
Which lots are affected?
Item XL-108323 Lot 761680 UDI (01)00880304651524(17)210713(10)761680 Item XL-108223 Lot 419460 UDI (01)00880304651494(17)210713(10)419460
Where was it sold?
USA (nationwide) and Internationally to ARGENTINA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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