ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including spine and cranium.
FDA device recall Z-2302-2015 · posted 2015-07-29 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
- Action taken
- Anspach sent an Urgent Notice: Medical Device Recall (Correction) letter of Anspach G1 Dissection Tools dated May 6, 2015, to all affected customers. Customers were not required to return their inventory of GI Dissection tools. Customers were instructed to complete, sign, and return the attached reply form confirming receipt of the letter by fax or email. Customers were also instructed to forward the letter as appropriate immediately. Customers with questions should contact the Complaint Handling Unit Manager at 561-494-3673 or contact their Anspach Sales Representative. For questions regarding this recall call 561-627-1080.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 88 tools.
- Distribution
- Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China.
- Date initiated
- 2015-04-13
- Date posted
- 2015-07-29
- Date terminated
- 2016-08-25
- Location
- Palm Beach Gardens, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANSPACH DISSECTION TOOLS (K113476) | The Anspach Effort, Inc. | 2011-12-16 |