DePuy Orthopaedics, Inc.: REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, 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.

Recall number

Z-1204-2014

Recalling firm

DePuy Orthopaedics, Inc.

Product

REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, 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.

Status

Terminated

Initiated

2014-02-24

Posted

2014-03-13

Terminated

2015-03-03

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 p

Root cause

Packaging

Action

DePuy Orthopaedics sent an Urgent Information - Recall Notice dated February 24, 2014, to all affected customers. The notice identified the product, reason for the recall and potential risks associated with using the recalled product. The notice includes response cards for the US Distributors to verify they have read, understood, and are adhering to the directions given in the field communication and for hospitals where consignment inventory is removed a hospital letter is available, as needed. No hospital signatures are required. Distributors are asked to send completed distributor cards to DePuy. Product related questions should be addressed to DePuy Orthopaedics, .Sales Consultant. Clinical questions should be addressed to DePuy Scientific Information Office 1-888-554-2482; recall questions to 574-371-4917.

Quantity

128

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.

Lot, serial or model codes

102325, 102326, 109315, 109316, 120082, 128475, 142843, 142845, 162487, 197812, 197813, 197814, 207924, 222654, 222657, 231689, 231690, 236435, 236442, 261758, 265711, 265714, 265715, 265717, 282997, 285154, 285155, 289096, 302804, 302807, 302808, 317754, 317755, 338154, 338155, 338157, 354580, 360635, 360636, 366432, 378645, 378647, 378650, 400505, 400506, 402456, 414735, 414736, 414737, 430481, 451998, 451999, 452448, 456741, 456742, 456743, 472193, 472194, 472195, 197401RA, D2WBJ4, DY5EF4, E3SD14, E49HN4, EW6HW4, EW6HX4, and FK8CR4

510(k) numbers

["K896048"]

PMA numbers

not on file

Product code

KRO

Firm FEI

1818910

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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