The Recall Desk
ModerateFDA (Devices)·Z-1981-2013·Announced 2013-08-28

Zimmer Recalls Moore Hip Prosthesis Stems for Sterile Barrier Testing

Zimmer is recalling 1,710 Moore Hip Prosthesis Long Fenestrated Stems to test sterile barrier integrity after a review of historic packaging validations.

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 and is a voluntary precautionary measure to test sterile barrier integrity, with no reported illnesses or injuries in the source text.

Plain-English summary

Zimmer, Inc. is recalling 1,710 units of the Moore Hip Prosthesis Long Fenestrated Stem, 203 mm Stem length. The product is used to seat the prosthesis with or without bone cement. The recall was initiated after Zimmer conducted a review of historic packaging validations, which determined that a subset of product packaged at a single facility required testing to ensure it met established requirements for sterile barrier integrity.

The affected products were distributed worldwide, including nationwide in the United States and in Singapore, Canada, Mexico, the Arab Emirates, Saudi Arabia, and Hong Kong. The specific states in the US distribution include CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VI, and WI.

Consumers and healthcare providers should stop using the affected products and contact Zimmer, Inc. for further instructions. The recall is limited to the specific lot codes and product configurations identified in the official recall notice.

The recalled product

Product
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
Manufacturer
Zimmer, Inc.
Affected units
1,710

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically: