Home / Recalls / DePuy Orthopaedics, Inc. / Z-1207-2014

Z-1207-2014 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

FDA device recall Z-1207-2014 was initiated by DePuy Orthopaedics, Inc. on Feb 24, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Mar 3, 2015). Affected quantity: 130.

Recall Details

Product Type
Devices
Report Date
Mar 19, 2014
Initiation Date
Feb 24, 2014
Termination Date
Mar 3, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
130

Product Description

REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-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.

Reason for Recall

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 pa

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapore, Slovenia, Spain, South Africa, Sweden, Switzerland, Turkey, United Kingdom, and Vietnam.

Code Information

Both left and Right 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517, 314828, 314831, 314832, 317759, 317761, 317765, 317769, 317770, 317772, 329335, 338170, 338171, 338173, 338176, 346442, 354609, 354614, 360644, 360645, 360646, 360647, 366437, 366439, 366440, 373257, 373258, 378654, 378655, 378657, 378660, 385029, 385031, 385033, 385034, 392028, 392029, 392032, 400543, 400544, 402441, 403009, 403012, 409586, 414761, 414762, 414763, 414764, 414765, 414766, 414767, 430493, 430494, 430495, 430496, 430498, 438592, 438593, 438594, 438595, 438596, 438597, 438598, 438599, 448539, 452452, 453170, 453171, 453172, 456749, 456751, 456752, 456753, 456754, 470494, 470496, 470503, 470504, D51B54, D51B64, D51B84, D51B94, DN5ET4, DY5EP4, E4EGG4, E5WCF4, E6CFK4, FD6G14, FE2DP4, FL8AM4

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1207-2014
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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FDA data resources