CLASS II Device recall · Reported 1 Jan 2014 · FDA Enforcement Report
Stryker Orthopaedics Ball Impactor Tip recalled
Stryker Howmedica Osteonics is recalling Stryker Orthopaedics Ball Impactor Tip, distributed nationwide in the US. The recall was initiated on 30 Sep 2013 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-0583-2014
- FDA event ID
- 66909
- Recalling firm
- Stryker Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Sep 2013
- FDA classified
- 26 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 30 Sep 2013 | Recall initiated by company | |
| 26 Dec 2013 | Classified by FDA | +87 days |
| 1 Jan 2014 | 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 received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
Where it was distributed
USA Nationwide Distribution
Questions about this recall
Is Stryker Orthopaedics Ball Impactor Tip recalled?
Yes. Stryker Howmedica Osteonics recalled Stryker Orthopaedics Ball Impactor Tip on 30 Sep 2013. The recall is Class II and its status is Terminated. Recall number Z-0583-2014.
Why was it recalled?
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
Which lots are affected?
Catalog number 1235-0-014 all lot codes
Where was it sold?
USA 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 21 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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|---|---|---|---|---|---|
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |