Recall Z-1382-2009 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Short Citation TMZF HA Hip Stem - Right; Hydroxylapatite Coated, Titanium Plasma Spray; V40 Taper, 132 degree neck angle: Stem Length - 102mm; Head Offset - 52mm, Distal Diameter - 16mm. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
| Date | Jul 22, 2009 (initiated Jan 6, 2009) |
| Status | Terminated |
| Reason | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
| Root cause | Process control |
| Action | An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that |
| Quantity | 1,628 total stems, all varieties. |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993768 | CITATION TMZF HA STEM Howmedica Osteonics Corp., Jan 21, 2000 |