Reported Jun 3, 2015 · Terminated

EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI…

DePuy Spine, 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: DePuy Spine, Inc. · 325 Paramount Dr · Raynham, MA · 02767-5199

Is this the product you have?

  • EXPEDIUM Spine System/Synapse System
  • MODEL
    • EXPEDIUM Offset Conical Lock Nut 8mm
    • CATALOG NO. : 1754-91-150
  • UDI NUMBER (if applicable)GTIN: 10705034032467
Lot codes and dates
  • LOT NUMBERARNDC6 & ARN DC7
Amount recalled
183 devices

Where it was sold

Why it was recalled

Device does not mate as intended.

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 Oct 3, 2018 · Data as of Sep 19, 6:12 PM UTC

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