Omnifit M/S PSL Shell 58 MM; Stryker Orthopaedics, Uses in primary and revision total hip arthroplasty which are indicat
FDA device recall Z-1053-2011 · posted 2011-02-07 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics determined that specific lots of the Omnifit Acetabular Shells may have a screw hole wall thickness that falls above the design specification.
- Action taken
- 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 Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance at (201) 972-2100.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MEH
- 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.
- Date initiated
- 2010-08-02
- Date posted
- 2011-02-07
- Date terminated
- 2012-11-09
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP (K912654) | Osteonics Corp. | 1991-08-16 |