Zimmer Manufacturing Recalls Bipolar Hip Liners Due to Sealer Calibration Issues
Zimmer Manufacturing B.V. is recalling 8,773 units of bipolar liners and shells for hip arthroplasty due to insufficient sealer calibration data.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 illnesses, injuries, or hospitalizations. The hazard is described as a data/calibration issue without explicit mention of a high-risk pathogen or immediate physical danger, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 8,773 units of bipolar liners and shells used in total or hemi hip arthroplasty. The recall affects products packaged in the firm's Building II between August 2010 and April 2013. The affected products are sterile.
The recall was initiated because of insufficient sealer calibration data for the affected product. The source text does not specify the exact nature of the defect or the potential clinical consequences of the calibration issue.
The recall covers US Nationwide Distribution. Consumers and healthcare providers should check their inventory against the specific lot numbers and item numbers listed in the official FDA recall notice Z-1114-2016 to determine if they possess affected units.
The recalled product
- Product
- Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 8,773
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.
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