Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
FDA device recall Z-0718-2014 · posted 2014-01-11 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- Recall was initiated due to the observation of separation between clear layers of the pouch during real time aging studies. As a result, it is possible to have a breach in the sterile barrier.
- Action taken
- Recalling firm notified direct accounts by letter on 09/09/11. Direct accounts were instructed to screen their inventory immediately for product packaged with the Tyvek Pouch/Tube Configuration, complete the reply form, and return the products to the firm.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- HTW
- Quantity affected
- 1,805,022 cutting burs and 55,026 irrigation clips
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jord
- Date initiated
- 2011-09-09
- Date posted
- 2014-01-11
- Date terminated
- 2016-04-15
- Location
- Palm Beach Gardens, FL
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