Reported Jun 21, 2017 · Terminated
VERSA-FX II STD TUBE 130DX16H, 130DX18H, 130DX20H, 135DX16H, 135DX18H, 135DX20H, 140DX16H, 140DX18H, 140DX20H,…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
VERSA-FX II STD TUBE 130DX16H130DX18H130DX20H135DX16H135DX18H135DX20H140DX16H140DX18H140DX20H145DX16H145DX18H145DX20H150DX16H150DX18H150DX20H
- Lot codes and dates
- 510K:K150818
- K954555 Item Numbers
001193130160011931301800119313020001193135160011931351800119313520001193140160011931401800119314020001193145160011931451800119314520001193150160011931501800119315020
- Lot Numbers
68 of 68 codes
6052843060528430R3675873687663689653690023689356106776561067765R6102032161020321R3690096108683061140159611511926116328661163286R6115121261246966612449156131452861314528R613093466132672361326723R3694546130934761309347R369477369477R6135292861352928R36955836983736982361625238617767823710769045003072372138953721437962388915623113516251128362547278624301756254730562461668623889176244594362430159625472863710907637109075371090776293159862950756629939536293478763004526
- Amount recalled
- 510
This recall covers 43 products
The agency filed one notice per product. You are reading one of them; the other 42 are below.
30 more are in the archive.
Where it was sold
Why it was recalled
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
This product could cause temporary or reversible health problems — stop using it.
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