Reported Jul 9, 2014 · Terminated

Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and…

Synthes, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417

Is this the product you have?

  • Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.
Lot codes and dates
  • All lots of part no
  • B37
    • 6350586
    • 6771518
    • 7086318
    • 7386422
    • 7523960
    • and 7548937
Amount recalled
44

Where it was sold

Why it was recalled

All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Dec 18, 2015 · Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.