Reported Mar 19, 2014 · Terminated
REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The…
DePuy Orthopaedics, 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 Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time.
- Lot codes and dates
64 of 64 codes
E1VHS4430482338164373256395802409578448220409582238688430483306508329330264451448222216275373255346439409580338165250929360638D65FJ4216277395804EJ7F14254740302815FF8DW4314821464642338166FA4FP4FA4FT4238411LC464643278448409579464640395803088411LA308248FF8DX4196411LA448227C1VCE4402352346437366433238687172188329332250931464641216274302813295384264453337411LA120084236445
- Amount recalled
- 134
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p
This product could cause temporary or reversible health problems — stop using it.
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