Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a compatible
FDA device recall Z-1163-2010 · posted 2010-03-18 · Terminated
Recall details
- Recalling firm
- Olympus America Inc.
- Reason for recall
- weak weld seams
- Action taken
- The recalling firm issued a Medical Device Recall letter dated February 8, 2010, informing their customers of the problem and the need to return the product.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KOG
- Quantity affected
- 45
- Distribution
- Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada
- Date initiated
- 2010-02-08
- Date posted
- 2010-03-18
- Date terminated
- 2010-05-25
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS OES LAPAROSCOPY SYSTEM (K923982) | Olympus Corp. | 1993-03-15 |
| ENDOSCOPE AND ACCESSORIES (K790071) | Olympus Corp. | 1979-04-02 |