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U.S. Department of Health and Human Services

Class 2 Device Recall Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee

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 Class 2 Device Recall Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Kneesee related information
Date Initiated by FirmApril 25, 2017
Create DateNovember 08, 2017
Recall Status1 Terminated 3 on February 06, 2018
Recall NumberZ-0070-2018
Recall Event ID 78299
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
ProductCustom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
Code Information Part Number: CP116574 Lot Number: 073840
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact411 Technical Services
575-371-3071
Manufacturer Reason
for Recall		A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.
Quantity in Commerce1
DistributionThis was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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