LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for prim
FDA device recall Z-1674-2023 · posted 2023-06-01 · Open, Classified
Recall details
- Recalling firm
- Linkbio Corp.
- 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).
- Action taken
- 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 complaints@linkbio.com for any questions.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 11 units
- Distribution
- US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX
- Date initiated
- 2023-04-25
- Date posted
- 2023-06-01
- Location
- Rockaway, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LinkSymphoKnee System (K202924) | Waldemar Link GmbH & Co. KG | 2021-05-13 |