Zimmer Biomet Recalls Custom Titanium Knee Implant Due to Nickel Content
Zimmer Biomet is recalling a custom titanium knee implant because it contained a nickel-containing screw, posing a risk to a patient with a nickel allergy.
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 involves a risk-of-harm product (implant containing an allergen for a specific patient) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling one unit of a Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee implant. The device was manufactured entirely from titanium specifically for a patient with a known nickel allergy. However, after the implant was used in the planned surgery, the manufacturer discovered that the assembly included a CoCrMo screw, which contains nickel.
The recall is limited to a single custom unit identified by Part Number CP116574 and Lot Number 073840. Because the product has already been implanted in the patient, it is not subject to return. The presence of the nickel-containing component in a device intended for a nickel-allergic patient presents a potential health risk.
Consumers and healthcare providers should be aware that this specific custom implant contains a component that contradicts the patient's medical requirements. No other units are affected by this recall.
The recalled product
- Product
- Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number: CP116574 Lot Number: 073840
Distribution
Distribution scope not specified by the agency.
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