Agency classClass IOur severity:Severe FDA (Devices)·Z-1699-2015·Announced 2015-06-17

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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv¿ femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse…"

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…
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: cytotoxicity
adverse-biological-response
Affected units: 752

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

Same manufacturer · Zimmer, Inc.

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Same hazard · cytotoxicity