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.
- Company
- Ethicon, Inc. Us
- Recall Initiated
- December 18, 2018
- Terminated
- May 29, 2020
- Recall Number
- Z-0747-2019
- Quantity
- 840
- Firm Location
- Somerville, NJ
Reason for Recall
The sutures inside the packaging are not the same size or type as indicated on the label.
Distribution
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.
Lot / Code Info
Product Lot MEH906
Root Cause
Packaging process control
Action Taken
Ethicon sent an Urgent Medical Device Recall notification letters to customers on 12/18/18. The letter identified the affected product, problem and actions to be taken. For questions contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266).
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