CLASS II ONGOING Device recall · Reported 1 Aug 2012 · FDA Enforcement Report
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill recalled
Stryker Howmedica Osteonics is recalling Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill, distributed nationwide in the US. The recall was initiated on 30 Apr 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2090-2012
- FDA event ID
- 62456
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Apr 2012
- FDA classified
- 26 Jul 2012
- Reported
- 1 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 30 Apr 2012 | Recall initiated by company | |
| 26 Jul 2012 | Classified by FDA | +87 days |
| 1 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an
Product as listed by the FDA
Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The Modular Stem bodies are made of TMZF alloy, developed specifically for orthopaedic applications. Rejuvenate Modular Necks The Rejuvenate Modular Necks are made of Cobalt Chrome. The necks in this system consist of 4 lengths in 4 mm increments. They are 30 mm, 34 mm, 38 mm and 42 mm. They come in multiple neck angles and versions in each length. They are 127, 130 and 132. The versions are 0, 8, 16 degrees. In total there are 16 unique neck implants in the Rejuvenate Modular System.
Where it was distributed
Nationwide Distribution
Questions about this recall
Why was it recalled?
Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an
Which lots are affected?
510 K092561 all lots Rejuvenate (NLS/NLV) Rejuvenate (SPT) (4845-4XXX and NLS/NLV)
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 62456This product is part of a recall event; the main page for the event is ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp recalled | Stryker Howmedica Osteonics | Other | Nationwide |
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All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
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| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |