Severity
Moderate
FDA Devices recall · Reported March 27, 2013
The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and a…
DePuy Orthopaedics, Inc. recalled ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hi… - a moderate-severity action.
ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hi… was recalled by DePuy Orthopaedics, Inc. in March 27, 2013. Reason: The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the…. Check the official notice for the remedy. Verify recall #Z-0972-2013 with the FDA Devices before acting.
The recall
DePuy Orthopaedics, Inc. issued this moderate-severity FDA Devices recall-The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0972-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0972-2013) was formally reported on March 27, 2013, with the manufacturer initiating the action on February 25, 2013. 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 750.
The documented reason for this recall is: The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential tha… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including the states of ME, MA, PA, MD, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, TN, NY, AR, NC and VA and the countries of Canada, Chile, Germany, Czech Repu…. 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.
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.
Severity
Moderate
Affected scope
750
Related Recalls
6
3 from same agency
ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
The tabs on the reamer extension device have broken. DePuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0972-2013 |
| Date reported | March 27, 2013 |
| Date initiated | February 25, 2013 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 750 |
| Distribution | Worldwide Distribution - USA including the states of ME, MA, PA, MD, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, TN, NY, AR, NC and VA and the countries of Canada, Chile, Germany, Czech Republic, Israel , Norwa… |
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.
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.
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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 27, 2013. 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.