Recall Z-1144-2016 ยท HWC Screw, Fixation, Bone
Zimmer Manufacturing B.V.
Product 46 consists of all product under product code: HWC and same usage: Item no: 114204012 MINI MAGNA-FX CANN SCREW 114204016 MINI MAGNA-FX CANN SCREW 114204020 MINI MAGNA-FX CANN SCREW 114204024 MINI MAGNA-FX CANN SCREW 114204028 MINI MAGNA-FX CANN SCREW 114204032 MINI MAGNA-FX CANN SCREW 114204036 MINI MAGNA-FX CANN SCREW 114204040 MINI MAGNA-FX CANN SCREW 114204044 MINI MAGNA-FX CANN SCREW
| Date | Mar 12, 2016 (initiated Jan 11, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 3190 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142442 | MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM Zimmer, Inc., Oct 3, 2014 |