Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics
FDA device recall Z-1982-2012 · posted 2012-07-10 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product.
- Action taken
- Stryker Orthopaedics sent an Urgent Product Recall letter dated January 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of any affected product. Customers were also asked to fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For any questions customers should call 201-972-2100. For any questions regarding this recall please call 201-831-5970.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 16,913 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-12-29
- Date posted
- 2012-07-10
- Date terminated
- 2015-03-19
- 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 |
|---|---|---|
| HOWMEDICA PREMIUM FEMORAL COMPONENT (K936127) | Howmedica, Inc. | 1994-10-26 |