Device product
PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Z-0747-2019
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 81820
- Status
- Terminated
- Classification
- Class II
- Quantity
- 840
- Official record key
device-enforcement:Z-0747-2019
Official wording
Reason: The sutures inside the packaging are not the same size or type as indicated on the label.
Code information: Product Lot MEH906
Distribution pattern: The products were distributed to the following US states: AR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, and WI.
Derived failure modes
-
Unknown
The sutures inside the packaging are not the same size or type as indicated on the label.