Zimmer Biomet Recalls Vanguard Total Knee Plates Due to Material Inclusions
Zimmer Biomet is recalling Vanguard Total Knee punch-through trial plates due to potential alumina inclusions in the raw material that could cause the instruments to crack or separate.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (cracking and separation) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is conducting a medical device recall for specific Vanguard Total Knee punch-through trial plates. The recall involves 26 units of the 63 mm, 67 mm, 71 mm, 75 mm, and 79 mm sizes. The affected products were distributed to Singapore and Malaysia, with no domestic distribution reported.
The recall is being conducted due to potential alumina inclusions in the raw material batch used to produce the affected products. These inclusions could lead to the cracking and separation of the instrument during use. The source text notes that the recall is for ARCOS & TPRLC broaches and rasps, while the structured product information identifies the specific items as Vanguard Total Knee punch-through trial plates.
Consumers and healthcare providers should stop using the affected products immediately. The specific lot numbers associated with the recall include ZB160701, ZB160702, ZB160703, and ZB160801, ZB160802, and ZB160803. Users should contact Zimmer Biomet for further instructions on how to return or replace the devices.
The recalled product
- Product
- Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Vanguard Total Knee
- PUNCH THRU TRL PLATES
- 63 MM Item No: 32-487261
- 67 MM Item No: 32-487262
- 71 MM Item No: 32-487263
- 75 MM Item No: 32-487264
- and 79 MM Item No: 32-487265
- Lot No's: ZB160701
- ZB160702
- ZB160703
- ZB160701
- ZB160801
- ZB160802
- ZB160803
Distribution
Distribution scope not specified by the agency.
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