USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm
Recall
- Recall Number
- Z-1217-2024
- Event Number
- 93858
- Firm
- United Orthopedic Corporation No.
- FEI Number
- 1000395711
- Product Code
- KRO
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 3, 2024
- Posted
- February 29, 2024
- Address
- 57 Park Avenue, 2, Science Park Hsinchu Taiwan
Description
USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11X150, PE25151213 - 13X150mm, PE25151215 - 15X150mm, PE25151217 - 17X150mm, PE25151415 - 15x200mm
Their is a potential that the implant curved stem may be oriented incorrectly.
On 1/18/24, United Orthopedic contacted consignees via phone to make them aware of the Urgent: Medical Device Recall that was being initiated. United Orthopedic also issued a Urgent: Medical Device Recall notification to affected consignees. United Orthopedic asked consignees to take the following actions: 1. Please examine your inventory immediately to locate the affected product whose quantities and lot numbers are listed above. 2. Please cease all use of these devices immediately and quarantine all affected devices in your territory for immediate return. 3. Customer Service will be contacting you regarding replacements, and you are requested to immediately return the affected product using the prepaid airbills on {insert RMA#}. a. Please write the RMA number on the outside of the box clearly and legibly. b. Please ship recalled product via Fed Ex standard overnight to: UOC USA INC. Attention: {insert RMA#} 15251 Alton Parkway, Suite 100 Irvine, CA 92618 (Attached Shipping Label) 4. Additionally, if your firm has further distributed the recall product, please provide that customer with a copy of this recall notification and assist them with the return of the product. 5. Please complete and return the following page in the enclosed, prepaid envelope. 6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
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