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Open, Classified

LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13

FDA Recall Z-1674-2023 · Posted 2023-06-01

Recalling FirmLinkbio Corp.
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2023-04-25
Product Quantity11 units

Reason for Recall

Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).

Firm Action

LinkBio Corp. issued Urgent Medical Device Recall on 4/25/23 via email to Distributors. 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. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. 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 [email protected] for any questions.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021-05-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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