Johnson & Johnson DuPuy Synthes Pinnacle Updated Field Safety Notice (Removal) (ICN 1241)
Important Customer Notice Recall
Ref: 2021/1241 ICN Number: 1241
- Johnson & Johnson, DuPuy Synthes has issued an updated Field Safety Notice replacing the notice issued 23 December 2020 and is now withdrawing specific lot number of the Pinnacle acetabular cup range following further discussions with the EU Coordinating Competent Health Authority.
- There is the potential of an out of specification condition namely an oversized minor diameter apex hole thread.
- When using the Pinnacle Cup devices with the optional Apex HE, potential clinical implications related to this issue, if not detected intraoperatively, include the following: surgical delay during retrieval or during replacement of the screw per surgeons’ choice, poor joint mechanics, loosening of the devise and pain.
- The updated instructions advise Physicians not to use the remaining affected Pinnacle cup devices, listed in attachment one, remaining in their inventory.
- Please refer to the Field Safety Notice that was issued by the supplier directly, dated 26 February 2021 for further information.
- There are 33 eDirect NHS Supply Chain product codes affected.
- Please refer to the Product Listing and Field Safety Notice for full details.(See our Downloads ▼ section).
- Please note the withdrawal should have no impact on future supplies of the products.
- Johnson & Johnson confirm all affected customers have already been contacted by them and provided with the Field Safety Notice.
- Follow the instruction in the Field Safety Notice including quarantining of the affected lot numbers.
- Complete all fields of the updated Business Response Form, page 3 of the notice, and return via email to MDFieldActionsUKIrl@its.jnj.com. Other options for return as detailed on the form.
- Contact your DePuy Synthes Sales Consultant to coordinate the return of any affected devices.
- Contact your local NHS Supply Chain Customer Service Advisor with details of affected products in your possession to enable us to monitor and manage the appropriate credit on your behalf.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.