Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported March 19, 2014
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 a
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 w…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
DePuy Orthopaedics, Inc. recalled REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Ri… - a moderate-severity action.
REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Ri… was recalled by DePuy Orthopaedics, Inc. in March 19, 2014. Reason: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches …. Check the official notice for the remedy. Verify recall #Z-1204-2014 with the FDA Devices before acting.
The recall
DePuy Orthopaedics, Inc. issued this moderate-severity FDA Devices recall-DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches ….
- Moderate
- severity level
- 128 units
- affected scope
- Class II
- classification
- March 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1204-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1204-2014) was formally reported on March 19, 2014, with the manufacturer initiating the action on February 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. DePuy Orthopaedics, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records list the affected scope as 128.
The documented reason for this recall is: 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 sh… Distribution data in the federal record shows the product reached: 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, Malaysi…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
128
Related Recalls
6
3 from same agency
Product description
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.
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 p
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1204-2014 |
| Date reported | March 19, 2014 |
| Date initiated | February 24, 2014 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 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 … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1204-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 128.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1204-2014.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1204-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported March 19, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.