Food, drugs, devices › DePuy Mitek, Inc., a Johnson & Johnson Co.
Device recall: Healix Knotless ADV BR 4.75 Suture Anchor
FDA enforcement event 84237 is a device recall by DePuy Mitek, Inc., a Johnson & Johnson Co. of Norwood, MA, initiated 4 Nov 2019 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 5 May 2020. Initiation: voluntary: firm initiated. DePuy Mitek, Inc., a Johnson & Johnson Co. has 16 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co., Norwood, MA.
Reason for recall
"Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation."
Distribution
"US: AL AZ CA CT FL IA IL IN LA MA MD ME MI MN MT NC NE NH NJ NM OH OK OR PA TN TX VA WA WI International: Belgium, Chile, China, Czech Republic, France, India, Japan, Korea, Latvia, New Zealand,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0665-2020 | Healix Knotless ADV BR 4.75 Suture Anchor | 299 | Class II | Terminated | 18 Dec 2019 |
| Z-0666-2020 | Healix Knotless ADV BR 5.5 Suture Anchor | 599 | Class II | Terminated | 18 Dec 2019 |
Context
Other enforcement events for DePuy Mitek, Inc., a Johnson & Johnson Co.
All 16 events for DePuy Mitek, Inc., a Johnson & Johnson Co.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: AL AZ CA CT FL IA IL IN LA MA MD ME MI MN MT NC NE NH NJ NM OH OK OR PA TN TX VA WA WI International: Belgium, Chile, China, Czech Republic, France, India, Japan, Korea, Latvia, New Zealand,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 5 May 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.