REF 623421 RS-ROM Noiles Rotating Hinge — Class II medical device recall Z-1208-2014
Terminated recall by DePuy Orthopaedics, Inc., reported 2014-03-19, distributed nationwide. DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches t
| Recall number | Z-1208-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DePuy Orthopaedics, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-02-24 |
| Classified | 2014-03-13 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2015-03-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, CN, CZ, DE, DK, EE, ES, FR, GB, HU, IE, IL, IN, IT, MY, NL, NO, NZ, PK, PL, PT, RU, SE, SG, SI, TR, VN, ZA |
| Quantity | 132 |
| Reason classes | sterility |
| Model numbers | 623421 |
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 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
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.