BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
Recall
- Recall Number
- Z-0728-2019
- Event Number
- 81762
- Firm
- Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
- FEI Number
- 3003386935
- Product Code
- MEH
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- December 4, 2018
- Terminated
- June 5, 2020
Description
BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
The firm, LinkBio Corp., Sent an "URGENT MEDICAL DEVICE RECALL" letter dated 12/4/2018 to its customers. The letter describes the product, problem and actions to be taken. The customers are instructed to do the following: Please identify your total inventory for this product. 1) Immediately cease use and segregate the above described product. 2) Complete the enclosed Consignee Reply Form, even if you have no inventory. 3) Return the above product and a copy of the Consignee Reply Form using Federal Express Account # 007183879 to: LinkBio Corporation 101 Roundhill Drive Rockaway, NJ 07446 Recall Return Authorization #: R-2018-02 Ensure that all users of the above products within your organization and other relevant persons have been notified of this safety information. If you have transferred the products to third parties, please pass on a copy of this information or notify the contact person indicated below. Should you have any questions or require assistance, please contact 1-973-625-1333 ext. 116 between 8:00 am - 5:30 pm (M-F) EST or email: [email protected] at any time.
US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
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