Recall Z-0693-2018 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Ethicon, Inc.
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
| Date | Aug 17, 2017 |
| Status | Terminated |
| Reason | On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing. |
| Root cause | Equipment maintenance |
| Action | On August 31, 2017 a Medical Device recall letter (Reference 2210968-08.31.17-003-R) was issued requesting customers to do the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to a |
| Quantity | 129,372 Eaches (Internationally) |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033746 | MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE ETHICON, Inc., Dec 18, 2003 |