ReClaim Reamer Extension
Medical device recall Z-0972-2013. Published in FDA’s Enforcement Report on Mar 27, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 27, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 27 states named in where it went
- 750 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
750, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Engraved Lot Number/ Label Lot Number J0111 / 578910 578913 R578910 R578912 R578913 In Kit # 2975-50-025 J0211/ In Kit # 2975-50-025 J0411/ 582631 In Kit # 2975-50-025 J0611/ In Kit # 2975-50-025 J0911/ 592125 In Kit # 2975-50-025 J1211/…
Every code shown here, 809 characters
Engraved Lot Number/ Label Lot Number J0111 / 578910 578913 R578910 R578912 R578913 In Kit # 2975-50-025 J0211/ In Kit # 2975-50-025 J0411/ 582631 In Kit # 2975-50-025 J0611/ In Kit # 2975-50-025 J0911/ 592125 In Kit # 2975-50-025 J1211/ 000003583 In Kit # 2975-50-025 NB12649 / NB12649 NB12650 / NB12650 NB12651 / NB12651 NB12652 / NB12652 NB12653/ NB12653 NB12654/ NB12654 NB12655/ NB12655 NB12656/ NB12656 NB23480/ NB23480 NB23481/ NB23481 NB3584 / In Kit # 2975-50-025 NB3586 / NB3586 NB3587 / NB3587 NB3588 / In Kit # 2975-50-025 NB3590 / NB3590 NB3591 / In Kit # 2975-50-025 NB5955 / NB5955 NB7894 / NB7894 In Kit # 2975-50-025 NB8016 / In Kit # 2975-50-025 NB8017 / NB8017 NB8018 / NB8018 In Kit # 2975-50-025 NB8019 / In Kit # 2975-50-025 NB8020 / NB8020 NB8021 / NB8021 NB8022 / NB8022 NB8023 /NB8023
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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 , Norway, Poland, Slovenia, Australia, New Zealand, South Africa, Belgium, Austria, Switzerland, France, England and County Cork, Ireland.
The states and territories these words name
27 states and territories.
Every one of them
- Arkansas
- Arizona
- California
- Colorado
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Montana
- North Carolina
- Nevada
- New York
- Ohio
- Pennsylvania
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 25, 2013.
- FDA classified it on Mar 20, 2013.
- FDA’s Enforcement Report published it on Mar 27, 2013.
- FDA terminated it on Dec 30, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- DePuy Orthopaedics, Inc., of Warsaw, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.