Date Initiated by Firm | August 07, 2017 |
Create Date | January 29, 2018 |
Recall Status1 |
Terminated 3 on March 29, 2019 |
Recall Number | Z-0476-2018 |
Recall Event ID |
78763 |
510(K)Number | K100238 |
Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
|
Product | Affixus Hip Fracture Nail, RH 130 DEG 9MM X 260MM |
Code Information |
Item No. 814509260; Lot No. (Exp. Date) UDI: 581640 (05/27/2027) UDI (01)00887868038853 (17)270527 (10)581640; 788410 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)788410; 892940 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)892940; 892950 (06/15/2027) UDI (01)00887868038853 (17)270615 (10)892950 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact | 574-371-3071 |
Manufacturer Reason for Recall | During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig. |
FDA Determined Cause 2 | Process change control |
Action | Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed. |
Quantity in Commerce | 638 units |
Distribution | US nationwide distribution. Also Portugal and the Netherlands. |
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.
|
510(K) Database | 510(K)s with Product Code = HSB
|