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Terminated

Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only

FDA Recall Z-0718-2014 · Posted 2014-01-11

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHTW
Date Initiated2011-09-09
Date Terminated2016-04-15
Product Quantity1,805,022 cutting burs and 55,026 irrigation clips

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.

Firm Action

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

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the countries of Japan, Canada, Nigeria, Guam, China, Czech Republic, Thialand, Ecuador, Lithuania, Argentina, Turkey, Cayman Island, Jamaica, India, Jordan, Germany, Brazil, Mexico, Israel, Cameroon, Switzerland, South Africa, Greece, Finland, Taiwan, Hong Kong, France, Spain, Cyprus, Australia, United Kingdom, Sweden, Bahama, Korea, Malaysia, Iceland, Portugal, Polan, Austria, Belgium, Egypt, Singapore, Netherland, Arab Emirates, Kenya, Italy, Venezula, Columbia, Dominican Republic, Chile, Panama, Honduras, Costa Rica, Philippines.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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