Reported Sep 30, 2020 · Terminated
Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971
ArthroCare Corporation
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: ArthroCare Corporation · 7000 W William Cannon Dr Bldg 1 · Austin, TX · 78735-8509
Is this the product you have?
- Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123
- UDI00817470006971
- Lot codes and dates
- Batch Numbers
78 of 78 codes
115485711798551184077119420820051531154858117985611840781194763200515411564291179857118482520015172005251116520911798581184826200151820052521166194117985911848272001519200549411689461181657118482820028282006014117092811816581184829200282920060371170929118257711848302002830200603811709301182578118483120028312006039117093111825791185959200283220060401174530118258011872532004741117453111825811187254200493311753571182621
- Batch Numbers
- Amount recalled
- 15,559 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.
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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