Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-01
FDA device recall Z-1251-2009 · posted 2009-04-17 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components.
- Action taken
- Urgent Product Recall letters, dated 1/30/2009, were sent to all Branches/agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons on January 30, 2009 via Federal Express. The letter asked consignees to examine their inventory and determine if they had any affected products, remove and quarantine affected product from their inventory, and complete the attached Product Recall Acknowledgment Form. The letter also stated that a Stryker Orthopaedics Sales representative would contact the consignee to reconcile and return the product . Consignees should contact their Stryker sales rep if they weren't not contacted by them. Questions should be directed to Colleen O'Meara at 201-831-5970.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- KRO
- Quantity affected
- 1161 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-01-30
- Date posted
- 2009-04-17
- Date terminated
- 2010-04-08
- 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 |
|---|---|---|
| MODULAR REPLACEMENT SYSTEM CEMENTED STEMS (K040749) | Howmedica Osteonics Corp. | 2004-06-17 |