Z-1206-2014Class II

REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R...

Name: Z-1206-2014 REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R...
Creator: DePuy Orthopaedics, Inc.
Published: 2014-02-24
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2014-02-24 / Terminated / root cause: packaging

FDA source

DePuy Orthopaedics, Inc. began a recall of REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is... on 2014-02-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1206-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-24
Posted: 2014-03-13
Terminated: 2015-03-03
Recalling firm: Depuy Orthopaedics Inc.
Product: REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, 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.
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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
Root cause tag: packaging
FDA 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 in commerce: 137
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.
Product codes and lots: 102932, 102933, 102934, 120086, 142854, 156155, 156156, 156157, 162493, 172189, 181460, 181462, 193663, 231692, 231695, 236448, 241369, 241371, 246794, 261763, 269712, 278450, 278451, 278452, 282999, 283000, 283001, 291033, 291034, 302817, 306511, 306512, 306513, 317757, 317758, 329334, 338167, 338168, 346440, 360639, 360640, 360641, 366434, 366435, 366436, 378652, 392023, 400513, 400514, 406837, 409583, 412683, 414752, 430490, 430491, 430492, 448537, 456744, 456745, 456747, 456748, 464644, 464646, 464647, 266411RA, 467411RB, D1TAN4, E1VHX4, E4EGB4, E73H74, E82E74, E82E84, E82E94, EN7JC4, EW6H24, FK8GP4, and FL1VH4.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1206-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1203-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13
Z-1204-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13
Z-1205-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13
Z-1206-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13
Z-1207-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13
Z-1208-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-19	2014-03-13

Product code KRO

K896048Class IIS-Rom/noiles Mark 3Joint Medical Products Corp. / cleared 1990-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)