Z-2618-2017Class II

DePuy Mitek LATARJET EXPERIENCE Top Hat Tap

Name: Z-2618-2017 DePuy Mitek LATARJET EXPERIENCE Top Hat Tap
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2017-05-12
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2017-05-12 / Terminated / root cause: design

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder... on 2017-05-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2618-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-12
Posted: 2017-06-20
Terminated: 2018-10-03
Recalling firm: DePuy Mitek, Inc.
Product: DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft
Product code: HWC Screw, Fixation, Bone
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
Root cause tag: design
FDA root cause: Component design/selection
Action: DePuy Mitek issued recall letter dated May 12, 2017 advising of the problem and requesting return of the product. A Response Form is to be completed and returned. Questions: contact your DePuy Synthes Mitek Sales Consultant or Carolyn Somerville, DePuy Mitek, Inc. (via telephone: 508.828.3647 Fax: 508.828.3762 or via email: [email protected]).
Quantity in commerce: 153 units
Distribution: US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK
Product codes and lots: GTN: (01)10886705026814 Lot codes: 16D01, 16D02, 16E01, 16J01, 16R01, 17A01, 17A02, 17C03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2618-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2615-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-20
Z-2616-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-20
Z-2617-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-20
Z-2618-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-20
Z-2619-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-28	2017-06-20

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)