Reported Mar 21, 2018 · Terminated

6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product…

Zimmer Biomet, 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: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

  • 6.5mm x 125mm x 16mm Cannulated Screw
  • Item Number110009948 (UDI: (01)00887868111327 (17)270421 (10)120910)
  • Product UsageThe 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar arthrodesis, and Fixation of pelvis and iliosacral joint
Lot codes and dates
  • Lot120910
Amount recalled
6

This recall covers 59 products

The agency filed one notice per product. You are reading one of them; the other 58 are below.

46 more are in the archive.

Why it was recalled

One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.

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 Apr 17, 2020 · Data as of Sep 19, 5:25 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.