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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 Knee see related information
Date Initiated by Firm April 25, 2017
Create Date November 08, 2017
Recall Status1 Terminated 3 on February 06, 2018
Recall Number Z-0070-2018
Recall Event ID 78299
Product Classification Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
Product Custom 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 Contact 411 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
Action The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.
Quantity in Commerce 1
Distribution This 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 Cycle TPLC 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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