Reported Oct 21, 2015 · Terminated

Inserter for Titanium Elastic Nails (TEN), orthopedic device

Synthes (USA) Products LLC

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 (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986

Is this the product you have?

  • Inserter for Titanium Elastic Nails (TEN), orthopedic device
Lot codes and dates
  • Part Number 359.219
  • lot numbers

    156 of 156 codes

    • 1095607
    • 3301017
    • 4826021
    • 5422955
    • 5718485
    • 8006578
    • 8017872
    • 1121876
    • 3325276
    • 4911859
    • 5455364
    • 5718486
    • 8007139
    • 8018319
    • 1641700
    • 3382583
    • 4911860
    • 5455365
    • 5718487
    • 8007472
    • 8114862
    • 1806500
    • 3410330
    • 4969014
    • 5485078
    • 7505411
    • 8008046
    • 8214803
    • 1811056
    • 3430483
    • 4971314
    • 5492810
    • 7565990
    • 8008261
    • 8326267
    • 1811059
    • 3493588
    • 5042001
    • 5496455
    • 7601112
    • 8009205
    • 8424513
    • 1813900
    • 3504996
    • 5066417
    • 5507788
    • 7619995
    • 8009363
    • 8476286
    • 1904339
    • 3524633
    • 5066418
    • 5525235
    • 7670741
    • 8009859
    • 8541845
    • 3005674
    • 3619119
    • 5090224
    • 5545372
Amount recalled
1550

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

potential for mechanical failures such as breakage.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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 4, 2016 · Data as of Sep 19, 5:19 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.