Product 60 consists of all product under product code: HSB and same usage: Item no: 225207055 RECON SCREW LG 5.5MM DIA 2
FDA device recall Z-1158-2016 · posted 2016-03-12 · Terminated
Recall details
- Recalling firm
- Zimmer Manufacturing B.V.
- 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.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 1394
- Distribution
- US Nationwide Distribution
- Date initiated
- 2016-01-11
- Date posted
- 2016-03-12
- Date terminated
- 2017-04-13
- Location
- Mercedita, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAMEDULLARY NAIL SYSTEM (K965098) | Zimmer, Inc. | 1997-02-28 |