LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04
FDA device recall Z-1514-2023 · posted 2023-05-04 · Open, Classified
Recall details
- Recalling firm
- Linkbio Corp.
- Reason for recall
- Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
- Action taken
- LinkBio issued Urgent Medical Device Correction letter on March 21, 2023 to US Distributors. Letter states reason for recall, health risk and action to take: Please take note of the amendment / reinforcement of the Surgical Technique and participate in future offering of product training on the updated technique. Two warnings have been added. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to follow the updated surgical technique. Attendance in future product training on the LINK SLED is required for continued use of the system. No action is required for devices which have already been implanted; continue with regular follow-up activities for patients who have received the LINK SLED knee system. All product lots of the above item numbers still within the labeled expiration date are in scope for this device correction. Waldemar Link GmbH & Co. KG is updating the surgical technique to incorporate the new warnings. The company will also be providing product training, through the LinkBio Medical Education team. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
- Root cause
- Labeling design
- Status
- Open, Classified
- Product code
- HSX
- Quantity affected
- 14 units
- Distribution
- NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Sau
- Date initiated
- 2023-03-21
- Date posted
- 2023-05-04
- Location
- Rockaway, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SLED UNICOMPARTMENT KNEE SYSTEM (K954186) | Link America, Inc. | 1996-01-26 |