The Recall Desk
HighFDA (Devices)·Z-2485-2012·Announced 2012-10-10

Biomet Recalls OptiLock Screw Inserters Due to Fit Issues

Biomet is recalling 268 OptiLock 2.7 mm Screw Inserters because they may not properly lock into screw heads, posing a risk of improper fixation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (improper fixation) where specific injury reports are not detailed in the source text, fitting the criteria for a High severity score.

Plain-English summary

Biomet, Inc. is recalling 268 units of the OptiLock 2.7 mm Screw Inserter (Catalog number 14-400795). The affected units are identified by lot numbers 133420, 409460, 469960, 487650, 487660, 627940, 627950, 797190, and 797200. These devices are part of the OptiLock Upper Extremity Plating System, intended for the fixation of fractures and osteotomies in the proximal humerus, olecranon, humerus, radius, and ulna.

The recall was initiated due to field complaints indicating that recent shipments of the 14-400795 and 36505 drivers do not properly mate or "lock" into specified screw heads. The issue occurs when drivers are near Maximum Material Condition (MMC) or are misshapen, causing them to fail to mate properly with screws at MMC. The design dimensions and tolerances of the drivers were not properly specified to prevent this incorrect fit.

The affected units were distributed nationwide in the United States, including states such as AL, GA, MT, AZ, WA, CA, IN, NY, NJ, VA, MA, MI, MD, PA, KY, NC, UT, NH, FL, OK, CO, LA, OH, MO, and SD. International distribution included Japan, the Netherlands, Australia, and Costa Rica. Healthcare providers should stop using the affected devices and contact Biomet for further instructions.

The recalled product

Product
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
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
268

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Catalog number: 14-400795
  • and lot numbers: 133420
  • 409460
  • 469960
  • 487650
  • 487660
  • 627940
  • 627950
  • 797190
  • and 797200.

Distribution

Distributed nationwide across the United States.

The notice also names 25 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · improper fit

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