CLASS II Device recall · Reported 10 Oct 2012 · FDA Enforcement Report
Optilock Screw Inserter recalled by Biomet
Biomet is recalling Optilock Screw Inserter, distributed nationwide in the US. The recall was initiated on 23 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2485-2012
- FDA event ID
- 63073
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Aug 2012
- FDA classified
- 28 Sep 2012
- Reported
- 10 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Masks, Gloves & PPE
Timeline
| 23 Aug 2012 | Recall initiated by company | |
| 28 Sep 2012 | Classified by FDA | +36 days |
| 10 Oct 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Optilock 2.7 mm Screw Inserter. Intended Use: The OptiLock Upper Extremity Plating System is intended for fixation of fractures and osteotomies. The System is intended for fractures and fracture dislocations, osteotomies and non-unions of the proximal humerus, particularly in osteopenic bone. The System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, particularly in osteopenic bone. The OptiLock VL Distal Radius Plating System is intended for use in distal radius and ulna (and other small bones), including use in osteopenic bone.
Where it was distributed
Worldwide Distribution-USA (nationwide) including the states of AL, GA, MT, TA, AZ, WA, CA, TA, IN, NY, NJ, VA, MA, MI, MD, PA, KY, NC, UT, NH, FL, OK, CO, LA, OH, MO and SD, and the countries of Japan, Netherlands, Australia, and Costa Rica.
Nationwide AlabamaArizonaCaliforniaColoradoFloridaGeorgiaIndianaKentuckyLouisianaMassachusettsMarylandMichiganMissouriMontanaNorth CarolinaNew HampshireNew JerseyNew YorkOhioOklahoma
Questions about this recall
Why was it recalled?
Field complaints indicate that recent shipments of the 14-400795 and 36505 drivers do not properly mate ("lock") into some of the specified screw heads. Drivers near MMC (Maximum Material Condition) or that are misshapen may not properly mate with screws at MMC. Design dimensions and tolerances of the drivers are not properly specified to prevent an incorrect fit between the drivers and the screw
Which lots are affected?
Catalog number: 14-400795; and lot numbers: 133420, 409460, 469960, 487650, 487660, 627940, 627950, 797190, and 797200.
Where was it sold?
Worldwide Distribution-USA (nationwide) including the states of AL, GA, MT, TA, AZ, WA, CA, TA, IN, NY, NJ, VA, MA, MI, MD, PA, KY, NC, UT, NH, FL, OK, CO, LA, OH, MO and SD, and the countries of Japan, Netherlands, Australia, and Costa Rica.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 63073| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Optilock T15 AO Driver recalled by Biomet | Biomet | Device Malfunction | Nationwide |
More recalls from Biomet
All 279| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |