LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126, Offset= 31 mm, T
FDA device recall Z-0769-2025 · posted 2024-12-26 · Open, Classified
Recall details
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for recall
- Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
- Action taken
- Link Bio Corp. Dover, NJ issued Urgent Medical Device Recall to Consignees via email on December 5, 2024. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LZO
- Quantity affected
- 3 units
- Distribution
- US Nationwide distribution in the states of AL, FL.
- Date initiated
- 2024-12-05
- Date posted
- 2024-12-26
- Location
- Norderstedt, Germany
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LINK MP RECONSTRUCTION PROSTHESIS (K142187) | Waldemar Link GmbH & Co. KG | 2014-11-06 |