FDA Device recall Z-1208-2014
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…
- FDA Device
- Class II
- terminated
- Published 2014-03-19
On 2014-03-19 the FDA classified a Class II recall of 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… by Depuy Orthopaedics, citing 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 wi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1208-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-02-24 |
| Published | 2014-03-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
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 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
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
Identifiers
| code_info | Both Right and Left 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499,…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1208-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.