DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VA
FDA device recall Z-0133-2013 · posted 2012-10-24 · Terminated
Recall details
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Reason for recall
- Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode
- Action taken
- The firm, Depuy Mitek, sent a "Medical Device Labeling Alert" letter dated March 14, 2012 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect your inventory to determine if any inventory of product code 227305 lot with the number M1108086 that is incorrectly labeled; review the following label information and the attached examples of correct and incorrect labels; and complete and return the Business Reply Form via fax to: 1-508-828-3750. To return the product call 1-877-379-4871 for an RGA and replacement product and return to DePuy Mitek, Attn: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324. Contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-48
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 376 units
- Distribution
- Nationwide distribution: USA including states of: AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MD, MI, MN, NJ, NY, OH, OR, TN, TX, UT, VA, and WA.
- Date initiated
- 2012-03-12
- Date posted
- 2012-10-24
- Date terminated
- 2015-06-05
- Location
- Raynham, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE (K082643) | Depuy Mitek, A Johnson & Johnson Company | 2008-12-19 |