ENDO-FUSE(TM) FUSION ROD 7 mm X 50 mm IMPLANT MATERIAL: STERILE R, Ti6A14V, CPTi, REF: 500005950, LOT 088605355, IMPLANT
FDA device recall Z-2589-2011 · posted 2011-06-17 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- Two lots- one lot of Endo-Fuse Fusion Rod, 7x50mm was commingled one lot of Endo-Fuse(R) Fusion Rod, 7x70mm. Not all parts in each lot are affected. The commingled rod sizes might not be detected prior to surgery.
- Action taken
- The firm, Wright Medical, sent an "URGENT: Medical Device Voluntary Recall" letter dated May 6, 2011 to their customers via FedEx . The letter describes the product, problem, and actions to be taken. The customers were instructed to examine their inventory for the affected products; immediately return any affected product to Wright Technology as soon as possible (contact Customer Service at 800-238-7117 for return instructions and replacement inventory), and immediately complete and return the attached response form via fax to: 901-867-7401. If you have any questions regarding this matter, please contact 800-874-5630.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 65
- Distribution
- Nationwide distribution: USA including states of: AL, AZ, CA, CO, FL, ID, IN, IL, LA, MI, MN, MO, NC, NE, NH, NY, OH, PA, SC, TN, TX, VA, VT, WA, and WI.
- Date initiated
- 2011-04-20
- Date posted
- 2011-06-17
- Date terminated
- 2012-12-27
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ROI FUSION RODS & PLATES (K051309) | Reiley Orthopaedics, Inc. | 2005-07-11 |