Recall Z-0885-2016 ยท LXH Orthopedic Manual Surgical Instrument
Biomet, Inc.
HipLOC CHS Plate/Lag Screw Introducer
| Date | Feb 25, 2016 (initiated Feb 16, 2016) |
| Status | Terminated |
| Reason | A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked. |
| Root cause | Process change control |
| Action | Biomet sent an " URGENT MEDICAL DEVICE RECALL NOTICE" dated February 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Remove the affected product from circulation. Review this notification and ensure that all affected personnel are aware of its contents. Carefully follow the instructions on the enclosed Response Form. Email a copy of the response form to CPWARFieldAction@zimmerbiomet.com |
| Quantity | 23 units |
| Distribution | US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.