Zimmer Recalls M/L Taper Hip Stems Due to Cytotoxicity Levels
Zimmer is voluntarily recalling 752 M/L Taper hip implants because they contain higher than allowed cytotoxicity levels, posing a risk of adverse biological response.
What this means for you
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 involves a medical device with a 'reasonable probability of adverse biological response' and subsequent revision surgery, which fits the High severity criteria for risk-of-harm products where specific injury counts are not yet reported.
Plain-English summary
Zimmer, Inc. is initiating a voluntary recall of 64 lots, totaling 752 implants, of M/L Taper with Kinectiv Technology femoral stems and modular necks. These products are semi-constrained hip prostheses used for total hip replacement in patients with conditions such as rheumatoid arthritis, osteoarthritis, and traumatic arthritis.
The recall is being conducted because the products were found to have higher than allowed cytotoxicity levels. The source text identifies a reasonable probability of an adverse biological response and subsequent revision surgery as the hazard associated with these implants.
The affected products were distributed worldwide, including in the United States (specifically in AK, AL, AZ, CA, FL, GA, IL, IN, KS, MA, MI, MN, MO, NC, NY, OH, OK, PA, TX, UT, VA, WA, and WI) and in Canada, Australia, Japan, Taiwan, France, Germany, Spain, and Italy. Patients who have received these implants should contact their healthcare provider for guidance regarding the recall and potential revision surgery.
The recalled product
- Product
- M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, pol
- Manufacturer
- Zimmer, Inc.
- Affected units
- 752
Distribution
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