| Class 2 Device Recall Enztec Femoral Impactor | |
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 |
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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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