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DePuy Mitek, Inc. FDA Inspection Record

FEI 1221934 · Inspections, Form 483s, warning letters and import refusals

DePuy Mitek, Inc. is an FDA-registered facility (FEI 1221934) located in RAYNHAM, MA, US. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 6, 2013: No Action Indicated (NAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm
16, latest Feb 24, 2025
Import refusals
5

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 6, 2013No Action Indicated (NAI)No citations listed
Oct 22, 2009Voluntary Action Indicated (VAI)No citations listed

Recalls

Showing the 10 most recent of 16 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

DateClassRecallProduct and reason
Feb 24, 2025Class IIZ-1314-2025COR Disposable Kit, 8 mm. Cartilage Transplant System. and 1 more product
Device is missing the pin in the graft loader component.
Apr 13, 2023Class IIZ-1677-2023DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone… and 4 more products
IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the…
Nov 4, 2019Class IIZ-0665-2020Healix Knotless ADV BR 4.75 Suture Anchor and 1 more product
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead…
Aug 30, 2018Class IIZ-0208-2019Mitek Screw and Washer Depth Gauge, Product Code 219024
The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
Dec 22, 2017Class IIZ-1749-2018LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE…
Reports of product loosening or coming unscrewed from the handle.
Aug 31, 2017Class IIZ-0695-20181113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to…
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
May 12, 2017Class IIZ-2615-2017DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product… and 4 more products
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to…
Nov 23, 2015Class IIZ-0479-2016VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring…
Nov 20, 2015Class IIZ-0656-2016FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to… and 2 more products
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
Aug 29, 2013Class IIZ-0191-2014DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product… and 1 more product
Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in…

FDA record score

11 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

17 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-1314-2025, this FEI as the recalling firmFeb 24, 20254 x 14
Class II recall Z-1677-2023, this FEI as the recalling firmApr 13, 20234 x 0.62.4
Class II recall Z-0665-2020, this FEI as the recalling firmNov 4, 20194 x 0.251
Class II recall Z-0208-2019, this FEI as the recalling firmAug 30, 20184 x 0.251
Class II recall Z-1749-2018, this FEI as the recalling firmDec 22, 20174 x 0.251
Class II recall Z-0695-2018, this FEI as the recalling firmAug 31, 20174 x 0.251
Class II recall Z-2615-2017, this FEI as the recalling firmMay 12, 20174 x 0.251
Class II recall Z-0479-2016, this FEI as the recalling firmNov 23, 201510 years or older, so it adds no points0
Class II recall Z-0656-2016, this FEI as the recalling firmNov 20, 201510 years or older, so it adds no points0
Class II recall Z-0191-2014, this FEI as the recalling firmAug 29, 201310 years or older, so it adds no points0
Class II recall Z-1278-2013, this FEI as the recalling firmApr 15, 201310 years or older, so it adds no points0
Class II recall Z-1172-2013, this FEI as the recalling firmMar 22, 201310 years or older, so it adds no points0
Class II recall Z-0529-2013, this FEI as the recalling firmNov 16, 201210 years or older, so it adds no points0
Class II recall Z-0140-2013, this FEI as the recalling firmSep 6, 201210 years or older, so it adds no points0
Class II recall Z-1937-2012, this FEI as the recalling firmMay 4, 201210 years or older, so it adds no points0
Class II recall Z-0133-2013, this FEI as the recalling firmMar 12, 201210 years or older, so it adds no points0
Inspection classified VAIOct 22, 200910 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
DePuy Mitek, Inc., A Johnson & Johnson Co.
Location
RAYNHAM, MA (US)
Source
device

Import refusals

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.