Reported Jan 13, 2021 · Terminated
Pinnacle Cups, Part numbers 121701048 121701050 121701052 121701054 121701056 121701058 121701060 121701062 121711048…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- Pinnacle Cups, Part numbers-
121701048121701050121701052121701054121701056121701058121701060121701062121711048121711052121712050121712052121712056121722048121722050121722052121722054121722056121722058121722060121722062121731048121731050121731052121731054121731056121731058121731060121731062121732048121732050121732052121732054121732056121732058121732060121732062121732064
- Product UsageThe PINNACLE CUP devices are part of the Pinnacle Hip Solution for the anatomic reconstruction of the hip joint, which promotes prosthetic joint load and function
- Lot codes and dates
- Lots
3,622 of 3,622 codes
859136285913618591363859283185941318593445859324585928308596365859413285944618596511859637185963728596369859649585965108597345859733885973478597351859414985973408597339859746585921658596366859746685928298597892859895585978988598954859734185973468597463859895385994398594152859842185973428599734859415585989568599793859980185997918599800859944885997928599447859894585996578599655859979085996698599656859989486000918599895
- Lots
- Amount recalled
- 14161 lots (10 units/lot)
Where it was sold
- Nationwide
Why it was recalled
Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
This product could cause temporary or reversible health problems — stop using it.
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