CLASS II Device recall · Reported 28 Jun 2017 · FDA Enforcement Report
DePuy Mitek Latarjet Experience Extraction Driver Product recalled
DePuy Mitek, Inc., a Johnson & Johnson is recalling DePuy Mitek Latarjet Experience Extraction Driver Product, distributed in 8 states. The recall was initiated on 12 May 2017 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-2619-2017
- FDA event ID
- 77252
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 May 2017
- FDA classified
- 20 Jun 2017
- Reported
- 28 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 12 May 2017 | Recall initiated by company | |
| 20 Jun 2017 | Classified by FDA | +39 days |
| 28 Jun 2017 | 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
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Where it was distributed
US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
ArizonaCaliforniaColoradoGeorgiaMassachusettsMichiganOhioWashington
Questions about this recall
Is DePuy Mitek Latarjet Experience Extraction Driver Product recalled?
Yes. DePuy Mitek, Inc., a Johnson & Johnson recalled DePuy Mitek Latarjet Experience Extraction Driver Product on 12 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2619-2017.
Why was it recalled?
Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
Which lots are affected?
GTN: 01)10886705026944 Lot codes: 16D01, 16D02, 16E02, 16J01, 17B02, 17B03, 17B04
Where was it sold?
US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, 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 21 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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