Reported Jun 17, 2020 · Terminated

A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for…

Biomet

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: Biomet · 6303 Blue Lagoon Dr Ste 100 · Miami, FL · 33126-6023

Is this the product you have?

  • A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW
  • Item Number110017551 -
  • Product UsageIntended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process
Lot codes and dates
  • Lot NumberP0217 (01)00887868135026(10)P0217
Amount recalled
5 OUS

This recall covers 22 products

The agency filed one notice per product. You are reading one of them; the other 21 are below.

9 more are in the archive.

Where it was sold

Why it was recalled

Distributed to the field without having completed design history files or design transfer activities

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 8, 2021 · Data as of Sep 19, 4:51 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.