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REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating… recallZ-1205-2014 · DePuy Orthopaedics, Inc. · initiated Feb 24, 2014

Class II Terminated All recalls posted in March 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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 p

FDA root cause category: Packaging

What the company is doing

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.

Recall details

Recall number
Z-1205-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Feb 24, 2014
Posted by the FDA
Mar 13, 2014
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
134
Product code
KRO
FDA submissions
K896048
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 description

REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, 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.

Code information (models, lots, serial numbers)

E1VHS4, 430482, 338164, 373256, 395802, 409578, 448220, 409582, 238688, 430483, 306508, 329330, 264451, 448222, 216275, 373255, 346439, 409580, 338165, 250929, 360638, D65FJ4, 216277, 395804, EJ7F14, 254740, 302815, FF8DW4, 314821, 464642, 338166, FA4FP4, FA4FT4, 238411LC, 464643, 278448, 409579, 464640, 395803, 088411LA, 308248, FF8DX4, 196411LA, 448227, C1VCE4, 402352, 346437, 366433, 238687, 172188, 329332, 250931, 464641, 216274, 302813, 295384, 264453, 337411LA, 120084, 236445, 289043, 329331, 308247, and 395806

Other devices under the same FDA submission

9 devices cleared under K896048 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 67627).

Sources and updates

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