Date Initiated by Firm | January 11, 2016 |
Date Posted | March 12, 2016 |
Recall Status1 |
Terminated 3 on April 13, 2017 |
Recall Number | Z-1137-2016 |
Recall Event ID |
72900 |
510(K)Number | K840643 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
|
Product | Product 39 consists of all product under product code: JDI
and same usage:
Item no:
32902605800 ION IMPLANTED FEM 22MM LO
32902604900 ION IMPLANTED FEM 26MM ME
32902603900 ION IMPLANTED FEM 26MM SH
For use in total or hemi hip arthroplasty |
Code Information |
lot no.: 62065298 62221052 62221052N 62093457 62185967 62268539 62334044 62268539N 61555436 62162471 62221049 62268540 62285362 62268540N 62285362N |
Recalling Firm/ Manufacturer |
Zimmer Manufacturing B.V. Turpeaux Industrial Park Rd 1 km 123.4 Mercedita PR 00715
|
For Additional Information Contact | Consumer Relations Call Center 800-447-5633 |
Manufacturer Reason for Recall | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
FDA Determined Cause 2 | Packaging |
Action | Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to
1.Review the notification and ensure that relevant personnel are aware of the contents.
2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative. |
Quantity in Commerce | 17 |
Distribution | US Nationwide Distribution |
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 = JDI
|