CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
Stryker Orthopaedics Trident Constrained Liner recalled
Stryker Howmedica Osteonics is recalling Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, and Non Sterile, distributed nationwide in the US. The recall was initiated on 3 Jun 2016 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-2281-2016
- FDA event ID
- 74500
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jun 2016
- FDA classified
- 25 Jul 2016
- Reported
- 3 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 3 Jun 2016 | Recall initiated by company | |
| 25 Jul 2016 | Classified by FDA | +52 days |
| 3 Aug 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.
Where it was distributed
Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMississippiNew Jersey
Questions about this recall
Why was it recalled?
Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
Which lots are affected?
Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012
Where was it sold?
Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.
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.
More recalls from Stryker Howmedica Osteonics
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|---|---|---|---|---|---|
| Device | CLASS II | Hoffmann LRF Safety Clip (Bone Transport Strut) 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 |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| 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 |