Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mate
FDA device recall Z-1614-2015 · posted 2015-05-14 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm.
- Action taken
- Stryker Orthopaedics an Urgent Medical Device Recall Letter/Notification Acknowledgement Form dated April 9, 2015 to their affected customers. The recall letter identified the affected product, problem and actions to be taken. Customers are asked to contact their Stryker Orthopaedics Sales Representative to arrange for return of the product if they have any of the affected items. Customers are asked to complete and return the acknowledgement form within 5 days by emailing to: so_m_product_field_action_response@stryker.com or faxed to: 1-855-251-3635. For question call 201-831-6365.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 4 units
- Distribution
- US Nationwide distribution in the states of MA and RI.
- Date initiated
- 2015-02-27
- Date posted
- 2015-05-14
- Date terminated
- 2016-10-13
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM (K904208) | Howmedica Corp. | 1991-04-01 |