Recall Z-0060-2017 ยท HWA Impactor
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
| Date | Oct 7, 2016 (initiated Aug 18, 2016) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker sent an Urgent Medical Device Recall Notification dated August 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Needed: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Branches/Agencies: Return all affected products available at your location to Stryker C/0 Stericycle 3. Hospitals/Branches: Complete and sign the enclosed Business Reply Form and fax a copy to 877-546-0444 or email t |
| Quantity | 3,768 units |
| Distribution | US and Internationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update Stryker Orthopaedics, May 25, 2016 |