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.
FDA Recall Z-0747-2019 · Posted None
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Recalling FirmEthicon, Inc.
Recall StatusTerminated
Product CodeGAP
Date Initiated2018-12-18
Date Terminated2020-05-29
Product Quantity840
Reason for Recall
The sutures inside the packaging are not the same size or type as indicated on the label.
Firm Action
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).
Root Cause
Packaging process control
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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