Recall Z-1057-2011 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Omnifit PSL M/S 3-Hole Cup, 50MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicated for painful, disabling joint disease resulting from degenerative arthritis, rheumatoid arthritis, post traumatic arthritis or late stage avascular necrosis.
| Date | Feb 7, 2011 (initiated Aug 2, 2010) |
| Status | Terminated |
| Reason | Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification. |
| Root cause | Device Design |
| Action | The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated August 2, 2010, via Federal Express to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory to identify the affected product; retrieve all affected product and return it their branch or agency warehouse for reconciliation; reconcile all product(s) on the attached Product Recall Acknowledgement Form and fax to (201) 831-6069, and return the affected product via Inter-Org Transfer and ship to the attention of Regulato |
| Distribution | Worldwide distribution: USA including states of: AL, AR, CA, FL, IN, ME, MI, MS, NC, NJ, OK, OR, WA , and WI; and countries including: China, Hong Kong and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912654 | OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP Osteonics Corp., Aug 16, 1991 |