Recall Z-2293-2015— The Anspach Effort, Inc.
Class II · Terminated
Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2015-04-13, terminated 2016-08-25. It names one FDA 510(k) clearance: K113476. Product: ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone including spine and cranium.. Reason: 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..
- Recalling firm
- The Anspach Effort, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-13
- Terminated
- 2016-08-25
- Firm location
- Palm Beach Gardens, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone including spine and cranium.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.