REF 623421 RS-ROM Noiles Rotating Hinge recall: Sterility Concern
REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral…
Why was REF 623421 RS-ROM Noiles Rotating Hinge 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 pa
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Both Right and Left 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
- Product
- REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral…
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 132
- Distribution
- 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.
- Recall date
- March 19, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)