Date Initiated by Firm |
July 08, 2020 |
Date Posted |
August 12, 2020 |
Recall Status1 |
Terminated 3 on October 08, 2020 |
Recall Number |
Z-2784-2020 |
Recall Event ID |
86023 |
510(K)Number |
K133930
|
Product Classification |
Plate, fixation, bone - Product Code HRS
|
Product |
Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus. |
Code Information |
Lot Number 1909660033; UDI 00840118115667 |
Recalling Firm/ Manufacturer |
Flower Orthopedics Corporation 100 Witmer Rd Ste 280 Horsham PA 19044-2647
|
For Additional Information Contact |
Robin Fatzinger 215-394-8903
|
Manufacturer Reason for Recall |
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
|
FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
The Regional Business Director notified the customer by telephone and informed them that there was an issue with the newly released calcaneus plates. The 6 units were requested to be returned to Flower Orthopedics. |
Quantity in Commerce |
25 |
Distribution |
US Nationwide distribution including in the states of AZ, FL, and OH. |
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 = HRS and Original Applicant = FLOWER ORTHOPEDICS CORPORATION
|