Recall Z-0450-2016— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2015-11-20, terminated 2016-09-08. It names 4 FDA 510(k) clearances: K111663, K082300, K072832 and 1 more. Product: 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.. 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..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-20
- Terminated
- 2016-09-08
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
4 on FDA's record- K111663 — TRAUMA INTERNAL FIXATION SYSTEMS
- K082300 — ANATOMIC LOCKING PLATING SYSTEM
- K072832 — ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
- K072083 — SMALL FRAGMENT LOCKING PLATING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.