The Recall Desk
ModerateFDA (Devices)·Z-1145-2016·Announced 2016-03-23

Zimmer Modular Hip Cups Recalled for Insufficient Sealer Calibration Data

Zimmer Manufacturing B.V. is recalling sterile modular hip cups due to insufficient sealer calibration data for products 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 a potential sterility issue due to calibration data gaps, which fits the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Manufacturing B.V. is recalling 30 units of sterile modular cups used in total hip arthroplasty. The affected products include various item numbers for 10-degree, 20-degree, and neutral liners under product code LPH. The recall is due to insufficient sealer calibration data for products packaged in the firm's Building II between August 2010 and April 2013.

The affected products were distributed nationwide in the United States. The source text does not specify the number of reported illnesses or injuries associated with this recall. Consumers and healthcare providers should check their inventory against the specific lot numbers listed in the official recall notice to determine if they possess affected units.

The recalled product

Product
Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 6110050
Affected units
30

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 →