Reported Jun 19, 2013 · Terminated

TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in…

American Optisurgical Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: American Optisurgical Inc · 26902 Vista Ter · Lake Forest, CA · 92630-8123

Is this the product you have?

TX1 Tissue Removal System disposable handpieces
Product UsageThe TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery

Lot codes and dates: Lot Numbers
00312-07
00713-06
00912-01
01813-02
02413-04
03113-02
04213-01
05113-01
05113-02
05512-03
05713-03
06313-05
06512-08
06513-02
07213-04
07912-06
08212-07
09412-03
11412-06
11612-05
12912-04
14512-07
15312-03
16412-07
17412-01
18712-06
19812-13
20212-03
21412-03
22212-03
23412-06
24112-06
24212-04
24912-13
25712-01
26912-01
27712-05
28512-03
28912-03
29612-01
30512-02
31112-05
32112-03
33112-01
34712-05
36612-01
Amount recalled: 1,436 units

Where it was sold

Why it was recalled

American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device.

This product could cause temporary or reversible health problems — stop using it.

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Is this the product you have?

Where it was sold

Why it was recalled

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