PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
This recall has been terminated (originally issued June 8, 2018).
- Company
- Ethicon, Inc. Us
- Recall Initiated
- June 8, 2018
- Terminated
- September 25, 2020
- Recall Number
- Z-2534-2018
- Quantity
- 72
- Firm Location
- Somerville, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Products do not meet a tensile strength specification
Distribution
Japan
Lot / Code Info
Lot Number: MCZ363
Root Cause
Under Investigation by firm
Action Taken
Johnson & Johnson Affiliate Japan notified consignees on 6/08/18 by customer letter through post or email or sales representative visits. Accounts requested to Examine inventory, remove and quarantine such product(s) and complete the Business Reply Form (BRF). Product to requested to be returned.
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