Micron Bobbin Vent Tube, 1.27 Mm I.D., Titanium, Ref… recallZ-0797-2010 · Gyrus ACMI Corporation · initiated Jan 8, 2010
Terminated All recalls posted in March 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gyrus ACMI Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Units of the product in lot MH136952 may have been shipped without being sterilized.
FDA root cause category: Pending
What the company is doing
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.
Recall details
- Recall number
- Z-0797-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 8, 2010
- Posted by the FDA
- Mar 4, 2010
- Recalling firm
- Gyrus ACMI Corporation
- Quantity
- 19 boxes of 6 units
- Product code
- ETD
- FDA submissions
- K820362
- Distribution
- Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
Product description
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.
Code information (models, lots, serial numbers)
Lot Number: MH136952.
Other devices under the same FDA submission
1 device cleared under K820362 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Gyrus ACMI 145224-ENTGyrus ACMI, LLC · Tube, Tympanostomy1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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