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U.S. Department of Health and Human Services

Class 2 Device Recall Enztec Femoral Impactor

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  Class 2 Device Recall Enztec Femoral Impactor see related information
Date Initiated by Firm August 16, 2019
Date Posted January 24, 2020
Recall Status1 Terminated 3 on March 02, 2023
Recall Number Z-0612-2020
Recall Event ID 84217
Product Classification Impactor - Product Code HWA
Product REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Code Information Lot number Distribution Date: 161471 08-Jun-16, 161472 08-Jun-16, 161473 08-Jun-16, 161474 08-Jun-16, 161475 08-Jun-16, 161476 08-Jun-16, 161477 08-Jun-16, 161756 29-Jun-16, 161757 29-Jun-16, 161758 29-Jun-16, 161759 29-Jun-16, 161760 29-Jun-16, 161761 29-Jun-16, 161762 29-Jun-16, 161822 22-Jul-16, 161823 22-Jul-16, 161824 22-Jul-16, 161825 22-Jul-16, 161826 22-Jul-16, 161827 22-Jul-16, 161828 22-Jul-16, 170760 24-Mar-17, 170761 24-Mar-17, 170762 24-Mar-17, 170763 24-Mar-17, 170764 24-Mar-17, 170765 24-Mar-17, 170766 24-Mar-17, 170767 24-Mar-17, 170768 24-Mar-17, 171989 23-Jun-17 ,
Recalling Firm/
Manufacturer		 Enztec Limited
26 Dakota Crescent, Sockburn
Christchurch New Zealand
For Additional Information Contact Marie Hadley
64-3-3480203
Manufacturer Reason
for Recall		 The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action On August 16, 2019, a Urgent Medical device recall for Product Correction" letter was emailed to affected consignees. In addition to informing the consignees about the recall, the
Quantity in Commerce 312 Femoral Impactors
Distribution CA
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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