FDA Device recall Z-2183-2018
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures by Zimmer Biomet, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2183-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-11 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
Reason
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.
Identifiers
| code_info | UDI: (01)00880304673885(17)230222(10)120150, Lot Number: 120150; UDI: (01)00880304673885(17)201203(10)140700, Lot Nu…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 N |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2183-2018%22
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