medical Class II Updated 2018-06-20

Zimmer Biomet, Inc. recalls Vanguard Knee System PS Tibial Bearing, Part Number 183621

Recalled Product

Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.


Hazard / Issue

The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150; UDI: (01)00880304673885(17)201203(10)140700, Lot Number: 140700; UDI: (01)00880304673885(17)211125(10)173480, Lot Number: 173480; UDI: (01)00880304673885(17)210520(10)205730, Lot Number: 205730; UDI: (01)00880304673885(17)210822(10)294370, Lot Number: 294370; UDI: (01)00880304673885(17)210310(10)338750, Lot Number: 338750; UDI: (01)00880304673885(17)210902(10)421970, Lot Number: 421970; UDI: (01)00880304673885(17)210916(10)516680, Lot Number: 516680; UDI: (01)00880304673885(17)210411(10)678370, Lot Number: 678370; UDI: (01)00880304673885(17)220603(10)700470, Lot Number: 700470; UDI: (01)00880304673885(17)201015(10)722060, Lot Number: 722060; UDI: (01)00880304673885(17)230130(10)775330, Lot Number: 775330; UDI: (01)00880304673885(17)220620(10)858220, Lot Number: 858220; UDI: (01)00880304673885(17)211101(10)888080, Lot Number: 888080; UDI: (01)00880304673885(17)220221(10)992290, Lot Number: 992290
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