Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 26, 2012
SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patien
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and he…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
DePuy Orthopaedics, Inc. recalled SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with … - a moderate-severity action.
SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with … was recalled by DePuy Orthopaedics, Inc. in December 26, 2012. Reason: An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement wi…. Check the official notice for the remedy. Verify recall #Z-0589-2013 with the FDA Devices before acting.
The recall
DePuy Orthopaedics, Inc. issued this moderate-severity FDA Devices recall-An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement wi….
- Moderate
- severity level
- Class II
- classification
- December 26, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0589-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0589-2013) was formally reported on December 26, 2012, with the manufacturer initiating the action on December 3, 2012. 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 1732 total all product codes.
The documented reason for this recall is: An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of p… Distribution data in the federal record shows the product reached: Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, a…. 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
1732 total all product codes
Related Recalls
6
3 from same agency
Product description
SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
Reason for recall
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0589-2013 |
| Date reported | December 26, 2012 |
| Date initiated | December 3, 2012 |
| Recalling firm | DePuy Orthopaedics, Inc. |
| Firm location | Warsaw, IN |
| Affected scope | 1732 total all product codes |
| Distribution | Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, … |
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-0589-2013) 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? ▼
SOL SYS R 9IN CALC 2.25/18 Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 1732 total all product codes.
Why was this product recalled? ▼
An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement varies depending on the femoral head. Worst case condition: Calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. It is evident that a
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 26, 2012. Severity: Moderate. Recall number: Z-0589-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0589-2013) 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 December 26, 2012. 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.