CLASS II ONGOING Device recall · Reported 1 May 2024 · FDA Enforcement Report
Vanguard Knee System AS Tibial Bearing / DCM ArCom recalled by Biomet
Biomet is recalling Vanguard Knee System AS Tibial Bearing / DCM ArCom, distributed nationwide in the US. The recall was initiated on 13 Mar 2024 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-1607-2024
- FDA event ID
- 94310
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Mar 2024
- FDA classified
- 22 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 13 Mar 2024 | Recall initiated by company | |
| 22 Apr 2024 | Classified by FDA | +40 days |
| 1 May 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
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
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
Where it was distributed
Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
Questions about this recall
Why was it recalled?
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
Which lots are affected?
Item Number: 189082; Lot Number: 65966530; UDI-DI: (01)00880304436954(17)280413(10)65966530;
Where was it sold?
Worldwide distribution - US Nationwide in the state of IN and the countries of Canada, India, Netherlands, and P.R. China.
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 26 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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