Recall Z-0797-2010
Gyrus ACMI Corporation · initiated January 8, 2010
Product
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.
Codes / lots: Lot Number: MH136952.
Reason for recall
Units of the product in lot MH136952 may have been shipped without being sterilized.
FDA-determined cause: Pending
Action taken
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.
Details
- Recall number
- Z-0797-2010
- Initiated
- January 8, 2010
- Posted by FDA
- March 4, 2010
- Terminated
- July 27, 2010
- Product code
- ETD – Tube, Tympanostomy
- Quantity
- 19 boxes of 6 units
- Distribution
- Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
- Recalling firm
- Gyrus ACMI Corporation, Southborough, MA