MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.
FDA Recall Z-0797-2010 · Posted 2010-03-04
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Recalling FirmGyrus ACMI Corporation
Recall StatusTerminated
Product CodeETD
Date Initiated2010-01-08
Date Terminated2010-07-27
Product Quantity19 boxes of 6 units
Reason for Recall
Units of the product in lot MH136952 may have been shipped without being sterilized.
Firm Action
The firm initiated their recall on 01/04/2010 by telephone or visit to their consignees. A follow-up Urgent: Medical Device Recall correspondence, dated 1/14/2010, was sent on 01/27/2010, return receipt requested, to both the consignees and the implanting surgeons. The follow-up letter identified the affected product and described the issue. Customers are to immediately cease any further use of any affected product and quarantine it. Also, they are to obtain a Return Goods Authorization and return the affected product to the firm. The reply form should be completed and also returned. Questions should be directed to customer service at 1-800-773-4301.
Root Cause
Pending
Distribution Pattern
Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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