Food, drugs, devices › DePuy Mitek, Inc., a Johnson & Johnson Co.
Device recall: DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-pow
DePuy Mitek, Inc., a Johnson & Johnson Co. (Raynham, MA) initiated this device recall on 15 Apr 2013; FDA lists 1 product record under event 64913, classified Class II.
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. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 11 Mar 2016. 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., Raynham, MA.
Reason for recall
"Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration."
Distribution
"Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1278-2013 | DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine. | 27 units | Class II | Terminated | 15 May 2013 |
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: "Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration."
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: "Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Mar 2016. "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.