Recall Z-1677-2023— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Ongoing
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2023-04-13. It names 4 FDA 510(k) clearances: K150209, K070925, K062170 and 1 more. Product: DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724. Reason: IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time.
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-13
- Firm location
- Norwood, MA, United States
510(k) clearances named in this recall
4 on FDA's record- K150209 — Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus +2 more
- K070925 — MODIFICATION TO: BIOKNOTLESS BR ANCHOR / LUPINE BR ANCHOR
- K062170 — BIOKNOTLESS AND LUPINE PLUS ANCHORS
- K040827 — PANALOK LOOP ANCHOR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
Reason for recall
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
Data sourced from openFDA. This site is unofficial and independent of the FDA.