Recall Z-0450-2016 ยท HRS Plate, Fixation, Bone
Biomet, Inc.
A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
| Date | Dec 18, 2015 (initiated Nov 20, 2015) |
| Status | Terminated |
| Reason | These screws have a single lead (instead of a triple lead) thread. The screw may sit proud in the plate, If the screw does not lock into the plate; the screw may back out. If the screw sits proud, soft tissue irritation may occur. If the screw does not lock into the plate and backs out, a revision surgery may be necessary. |
| Root cause | Process change control |
| Action | On 11/20/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors, hospital risk managers, and implanting surgeons via courier. Distributors were instructed to locate and return the affected product, hospitals to locate and discontinue use, and implanting surgeons to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday throug |
| Quantity | 182, 965 |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR CHILE, COSTA RICA, NETHERLANDS, CANADA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072083 | SMALL FRAGMENT LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc., Oct 25, 2007 |
| K072832 | ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc., Dec 14, 2007 |
| K082300 | ANATOMIC LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc., Feb 18, 2009 |
| K111663 | TRAUMA INTERNAL FIXATION SYSTEMS DePuy Orthopaedics, Inc., Mar 12, 2012 |