Moderate FDA (Devices)·Z-1168-2016·Announced 2016-03-23

Zimmer Versys Heritage Femoral Stem Recall Due to Sealer Calibration

Zimmer Manufacturing B.V. is recalling 360 units of Versys Heritage Femoral Stems due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is related to insufficient calibration data, which is a quality control issue without reported adverse health consequences, fitting the criteria for a moderate severity score.

Plain-English summary

Zimmer Manufacturing B.V. is recalling 360 units of Versys Heritage Femoral Stems. The recall is being conducted because of insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile and are used in total or hemi hip arthroplasty.

The recall covers specific item numbers under product code JDI, including 785701000, 785701100, 785701200, 785701300, 785701320, 785701400, 785701420, 785701500, 785701520, 785701600, and 785701700. The affected lots include 61661156, 61966578, 62225735, 61873650, 61962858, 62137227, 62137228, 62240762, 62340060, 62340060N, 61820823, 61881193, 61957419, 61962855, 62172047, 62175238, 62234460, 62262787, 62291935, 62298291, 62298292, 62310454, 62314656, 62340058, 62298291N, 62310454N, 62314656N, 62340058N, 61878467, 61881194, 61883397, 61886939, 61899754, 61968010, 62221008, 62284504, 62285272, 62291937, 62291937N, 61822322, 62032180, 62260128, 62304808, 62340062, 62358896, 62304808N, 62340062N, 61813932, 61820819, 61980168, 62205493, 62240263, 62240771, 62240772, 62240773, 62240774, 62282932, 62291138, 62291938, 62296576, 62299089, 62340063, 62296576N, 62340063N, 61866252, 62257147, 62303509, 62340064, 62340064N, 61814493, 61976178, 62046502, 62240775, 62312492, 61679898, 61995953, 61995956, 61995957, 61995958, 61885901, 62046499, 62211984, 370462, and 61980171.

The affected products were distributed nationwide in the United States. Healthcare providers and patients should contact Zimmer Manufacturing B.V. for further instructions regarding the return or replacement of these devices.

The recalled product

Product: Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300 VERSYS HERITAGE FEM STEM 785701320 VERSYS HERITAGE FEM STEM 785701400 VER
Manufacturer: Zimmer Manufacturing B.V.
Category: Medical Device — Orthopedic Implants
Hazard: sterility-compromise
quality-control
Affected units: 360

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 72 recalled by Zimmer Manufacturing B.V. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 72 products in this recall →

Same manufacturer · Zimmer Manufacturing B.V.

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