Zimmer Manufacturing Recalls Hip Femoral Heads Due to Calibration Issues
Zimmer Manufacturing B.V. is recalling 35,032 hip femoral heads due to insufficient sealer calibration data. The affected sterile products were packaged between August 2010 and April 2013.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences. The hazard involves potential sterility compromise due to calibration issues, which is a significant risk for implanted medical devices, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Manufacturing B.V. is recalling 35,032 units of hip femoral heads (product code LPH) used in total or hemi hip arthroplasty. 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 are sterile. The recall covers specific lot numbers listed in the official notice and was distributed nationwide in the United States.
Consumers and healthcare providers should check their inventory for the affected lot numbers. If the products are found, they should be removed from use and returned to the manufacturer or the FDA as directed.
The recalled product
- Product
- Product 2 consists of all products product code LPH, and same usage: 801802202 12/14 COCR FEMORAL HEAD 2 801802220 12/14 COCR FEMORAL HEAD 2 801802230 12/14 COCR FEMORAL HEAD 2 801802601 12/14 COCR FEMORAL HEAD 2 801802602 12/14 COCR FEMORAL HEAD 2 801802603 12/14 COCR…
- Manufacturer
- Zimmer Manufacturing B.V.
- Affected units
- 35,032
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 →Related recalls
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