Reported Aug 26, 2015 · Terminated
Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve…
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?
- Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long; Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long are system specific instruments to the 3.5 mm Low Profile Pelvic System Retractor Set.
- Lot codes and dates
- Part Numbers 03.100.013 03.100.014
- with lot numbers/ A7OA43 908057 / A7PA10 909551 / A7PA20 910819 /
5001180500118150437205043721504372250437235056224505641050564115101097510606451093235162016520791752523535252354530391453039165626912904732
/ A7OA37 904731 / A7OA43 908058 / A7PA10 909552 / A7PA20 910911 /A7PA30T100870T104992T108114T114599T938508T939338T939640T942069T945414T946497T949375T954443T958062T963371T968151T968381T972086T974174T974550T977901T980418T980555T983069T984285T987813T993091T996572T9999675001182500118350429205042921504292250429235056851508708150870825109324510932551093265109327516201252079185252394525642152564795256480530575853057595305760587709560402206040225604022660561336056134903786
A7PA31T100871T104993T108115T114598T932954T935264T939339T945413T946498T947785T954444T958061T963372T968152T974175T977904T980511T983070T984228T987809T989000T993092T996565T999969
- Amount recalled
- 1113
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
- Nationwide
Why it was recalled
Potential for micropores to form, allowing fluid to enter the hollow handle.
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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