CLASS II Device recall · Reported 31 Oct 2018 · FDA Enforcement Report
Mitek Screw and Washer Depth Gauge, Product recalled
DePuy Mitek, Inc., a Johnson & Johnson is recalling Mitek Screw and Washer Depth Gauge, distributed nationwide in the US. The recall was initiated on 30 Aug 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0208-2019
- FDA event ID
- 81059
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Aug 2018
- FDA classified
- 23 Oct 2018
- Reported
- 31 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Aug 2018 | Recall initiated by company | |
| 23 Oct 2018 | Classified by FDA | +54 days |
| 31 Oct 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Mitek Screw and Washer Depth Gauge, Product Code 219024
Where it was distributed
US nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan, Jordan, Netherlands, Poland, Slovenia, Sweden, Turkey, UK.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisKansasKentuckyLouisianaMassachusettsMichiganMissouriMontanaNorth CarolinaNebraskaNew Hampshire
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI: 10886705005390; Lot Numbers: 0005178 1103107 0009101 1105132 0009181 1112106 0102157 1201104 0103045 950229 0205355 961232 0207451 970198 0208597 971229 0301615 980585 0302184 9809121 0303337 990765 0311333 C000007655 0311389 C000012527 0512552 C000020182 0605571 1000196842 0612501 1000415749 0707512 1000431580 0710501 1000661713 0801536 1001119996 0809117 1002144 0905130 1006113 0912100 1008120 1000064514 1103103
Where was it sold?
US nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MI, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, WA, WI. The products were distributed to the following foreign countries: Australia, Canada, Chile, China, Chechnya, Denmark, Italy, Japan, Jordan, Netherlands, Poland, Slovenia, Sweden, Turkey, UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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