Recall Z-0875-2016 ยท MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
| Date | Feb 25, 2016 (initiated Jan 21, 2016) |
| Status | Terminated |
| Reason | During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. |
| Root cause | Under Investigation by firm |
| Action | Stryker Orthopaedics sent an Urgent Medical Device Removal letter and Customer Response forms dated January 21, 2016 through UPS. The letter identified the affected product, problem, actions to be taken including forwarding notice if applicable, returning all affected products and completing and returning the Customer Response form to Stericycle.by the instructions provided. |
| Quantity | 147,838 units in total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123604 | ABG III MONOLITHIC HIP STEM Howmedica Osteonics Corp., Aug 16, 2013 |