Z-1553-2015 Class II Terminated
FDA device recall Z-1553-2015 was initiated by The Anspach Effort, Inc. on Mar 24, 2015 and is designated Class II. Reason for recall: The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential… The recall status is terminated (terminated Dec 14, 2016). Affected quantity: 12,085 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2015
- Initiation Date
- Mar 24, 2015
- Termination Date
- Dec 14, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,085 pieces
Product Description
Reason for Recall
Distribution Pattern
Worldwide Distribution - US (nationwide including DC, Hawaii, and Puerto Rico) and Internationally to Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Brazil, Canada, China, Chile, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Great Britain, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, Kenya, Korea, Kuwait, Lebanon, Sri Lanka, Libyan Arab Jamahiriya, Morocco, Macedonia, Mexico, Malaysia, Netherlands, Norway, Nepal, New Zealand, Oman, Ontario, Peru, Philippines, Palestine, Portugal, Romania, Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, South Africa, El Salvador, Thailand, Turkey, Taiwan, Ukraine, Uruguay, Venezuela, Vietnam and United Arab Emirates.
Code Information
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1553-2015
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026