| Date Initiated by Firm |
March 26, 2018 |
| Create Date |
April 20, 2018 |
| Recall Status1 |
Terminated 3 on November 18, 2020 |
| Recall Number |
Z-1469-2018 |
| Recall Event ID |
79681 |
| 510(K)Number |
K101622
|
| Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
|
| Product |
Zimmer Natural Nail System Tear Drop Guide Wire
3.0 mm Diameter, 100 cm Length; Item Number: 47-2490-097-00 |
| Code Information |
Lot Numbers: 63609177 63631715 63638172 63638173 63638175 63638176 63645643 63645644 63655990 63655991 63655992 63655993 63655994 63662538 63662539 63662540 63662541 63668694 63668695 63668696 63668697 63675668 63675669 63675670 63675704 63675705 63681724 63681726 63681728 63690176 63690179 63690180 63705228 63705229 63709163 63709164 63709165 63709166 63715680 63715681 63715682 63715683 63721368 63721369 63721370 63721371 63731169 63748392 63753760 63753761 63753762 63753763 63758420 63758421 63758422 63758423 63771066 63771067 63780119 63780120 63780121 63780122 63781875 63781876 63781877 63781878 63787475 63787476 63787477 63796531 63796532 63796533 63796534 63796535 63803579 63803581 63803583 63803591 63803592 63812281 63812283 63812284 63812285 63817702 63817704 63817705 63844026 63812282 63817701 63826234 63826235 63836285 63844028 |
Recalling Firm/
Manufacturer |
Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
|
| For Additional Information Contact |
411 Technical Services
574-371-3071
|
Manufacturer Reason
for Recall |
Potential failure of sterile packaging seal.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided. |
| Quantity in Commerce |
19483 total products |
| Distribution |
US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad |
| 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 and Original Applicant = ZIMMER, INC.
|
