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EpiDisc TM Perf Patch Kit
Anika Therapeutics, Inc. · Model 653-160 · UDI-DI 08033549790752
10
510(k) clearances
23
Adverse events
2
Recalls
25
Facilities
Description
EpiDisc TM Perf. Patch Kit is used during myringoplasty as an adjunct to aid in the healing of tympanic membrane perforations.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-22 | Cook Biotech, Inc. | Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products. |
| 2015-10-26 | Merz North America, Inc. | The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect. |
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