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U.S. Department of Health and Human Services

Class 2 Device Recall GENESIS(R) II TIBIAL Punch

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 Class 2 Device Recall GENESIS(R) II TIBIAL Punchsee related information
Date Initiated by FirmMay 04, 2018
Create DateJune 11, 2018
Recall Status1 Terminated 3 on February 22, 2019
Recall NumberZ-2163-2018
Recall Event ID 80125
510(K)NumberK121393 
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Productsmith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
Code Information 15FM16181
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact
901-396-2121
Manufacturer Reason
for Recall		One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
FDA Determined
Cause 2		Error in labeling
ActionThe firm initiated the recall by email on 05/04/2018. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return.
Quantity in Commerce5 units
DistributionInternational only: United Arab Emirates, Spain, Mexico
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.
510(K) Database510(K)s with Product Code = MBH
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