Z-0728-2019Class II

BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is...

Name: Z-0728-2019 BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2018-12-04
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2018-12-04 / Terminated / root cause: manufacturing process

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of 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... on 2018-12-04. FDA classified it as Class II and gives the reason as "The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0728-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-04
Posted: 2019-01-11
Terminated: 2020-06-05
Recalling firm: Waldemar Link GmbH & Co. KG
Product: 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.
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 30
Distribution: US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
Product codes and lots: Lot# 1707121

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0728-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0728-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-11
Z-0729-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-11

Product code MEH

K171273Class IILINK® BiMobile(TM) Dual Mobility SystemWaldemar Link GmbH & Co. KG / cleared 2018-01-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)