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

Is my product affected?

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

• UPC 00880304673885

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

What happened

Zimmer Biomet is recalling 169 units of the Vanguard Knee System PS Tibial Bearing (Part Number 183621) used in knee replacement procedures. The recall was issued because the label master file incorrectly specified the product size as 63/37mm instead of the correct 63/67mm. However, the actual product itself is laser marked with the correct 63/67mm size, and no 63/37mm size is manufactured. The recalled units were distributed worldwide, including to multiple U.S. states (Arkansas, California, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Mississippi, North Carolina, Ohio, Pennsylvania, Tennessee, Texas, and West Virginia) and Canada.

The affected units are identified by specific lot numbers: 120150, 140700, 173480, 205730, 294370, 338750, 421970, 516680, 678370, 700470, 722060, 775330, 858220, 888080, and 992290, each with corresponding UDI codes. The source document does not specify a remedy for affected consumers.

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

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution: US (nationwide) to states of: AR, CA, FL, GA, IL, IN, KS, MI, MN, MS, NC, OH, PA, TN, TX, and WV and country of: Canada. Quantity: 169 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

Source

Official record: FDA (Device enforcement) ↗

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

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