Biomet Sports Medicine
Warsaw, IN, US
Biomet Sports Medicine appears in FDA device records in Warsaw, IN. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Biomet Sports Medicine between 2007 and 2014. The busiest year on record is 2007, with 4. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 4 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 4 |
| 2013 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140908 | JUGGERKNOT MINI SOFT ANCHOR | DZL | Substantially Equivalent | |
| K122437 | NO-PROFILE SCREWS NO-PROFILE WASHER NO-PROFILE SCREWS WASHERLOC WASHERS | MBI | Substantially Equivalent | |
| K123485 | JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOF | MBI | Substantially Equivalent | |
| K110879 | BIOMET SPORTS MEDICINE JUGGERKNOT (TM) MINI SOFT ANCHOR | MBI | Substantially Equivalent | |
| K111564 | MAXFIRE MARXMEN MENISCAL REPAIR DEVICE | MBI | Substantially Equivalent | |
| K110039 | BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM | JDQ | Substantially Equivalent | |
| K103145 | HAMMERLOC TM TIBIAL FIXATION DEVICE | MBI | Substantially Equivalent | |
| K101063 | SLEEVE WITH ZIPLOOP FIXATION DEVICES | MBI | Substantially Equivalent | |
| K083070 | TOGGLELOC SYSTEM | MBI | Substantially Equivalent | |
| K071816 | HARPOON SUTURE ANCHOR | HWC | Substantially Equivalent | |
| K071704 | SLEEVE AND BUTTON SOFT TISSUE DEVICES | MBI | Substantially Equivalent | |
| K070389 | PEEK KNOTLESS ANCHORS | HWC | Substantially Equivalent | |
| K071498 | SUBTALAR IMPLANT | HWC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0582-2012 | Artificial Ligament Fixation Device 15MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 25MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 20MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 30MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device 35MM TI NS ToggleLoc (TM) W/Continuous Maxbraid Polyethylene Suture Loop TO Gal 4V Alloy/Polyethylene; Artificial Ligament Fixation Device #7 PE Ziploop (TM) ToggleLoc (TM). Toggleloc anchors are indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction. | Six sizes of ToggleLoc, Artificial Ligament Fixation Device, have been manufactured with the suture pull hole drilled in the wrong location on the device. The ToggleLoc implant is deployed with a suture that pulls the device through the tunnel. The hole being drilled in the wrong location will orient the device to pass through the tunnel with the angled end of the implant first. This may caus | Terminated | ||
| Z-1783-2008 | BIOMET EZLoc 9-10mm TM Femoral Fixation, Catalog Number 904781. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction. | This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1 | Terminated | ||
| Z-1782-2008 | BIOMET EZLoc 7-8mm TM Femoral Fixation, Catalog Number 904780. The Ezloc Is indicated for use for fixation of tendons & ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) reconstruction. | This recall was initiated following an investigation which identified that: EZLoc Femoral Fixation devices, from two finished good lots were distributed with the incorrect component size inside the package. As supplied, label indicates product size as EZLoc 7-8mm 904780 L305240. Actual product enclosed may be EZLoc 9-10mm. Alternatively, as supplied, label indicates product size as EZLoc 9-1 | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain