Reported Mar 2, 2016 · Terminated
CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is…
Zimmer Biomet, 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: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip
- System is indicated for cemented use inPatients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures."
- Lot codes and dates
- Item numbers
00-8114-000-0000-8114-000-1000-8114-001-0000-8114-001-1000-8114-002-0000-8114-002-1000-8114-002-1800-8114-002-3000-8114-003-0000-8114-003-1000-8114-003-1800-8114-003-3000-8114-004-0000-8114-004-1000-8114-004-2000-8114-004-2300-8114-004-2600-8114-004-3000-8114-005-0000-8114-005-1000-8114-005-3000-8114-012-1800-8114-013-18
- Lot numbers
853 of 853 codes
617444626174447161767815617706206177406761774069617740706177407161778347617783526177934561783709617837106178371261783713617837156178371661783717617870126178702661787032617870336178703961790491617904936179050161790503617949976179499861794999617950016179500261798096617980976180116361801166618011676180116961801170618011726180117361801175618038526180385361803854618038556180385661803857618067806180678161806783618067846180678561806786618067956180911661809117618091186180911961809120
- Item numbers
- Amount recalled
- 24272
This recall covers 21 products
The agency filed one notice per product. You are reading one of them; the other 20 are below.
8 more are in the archive.
Where it was sold
- Nationwide
- FL
Why it was recalled
LDPE bag containing the implant adheres to the highly polished implant surface.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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