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
109560733010174826021542295557184858006578801787211218763325276491185954553645718486800713980183191641700338258349118605455365571848780074728114862180650034103304969014548507875054118008046821480318110563430483497131454928107565990800826183262671811059349358850420015496455760111280092058424513181390035049965066417550778876199958009363847628619043393524633506641855252357670741800985985418453005674361911950902245545372
- 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.
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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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