Z-1550-2023Class II
LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
LinkBio Corp. / initiated 2023-03-21 / Open, Classified / root cause: labeling and UDI
Linkbio Corp. began a recall of LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11 on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1550-2023
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- LinkBio Corp.
- Product
- LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
- Product code
- KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- 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
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling design
- Action
- 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 [email protected] for any questions.
- Quantity in commerce
- 3 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, Saudi Arabia, Ukraine, Vietnam, and Belarus
- Product codes and lots
- UDI-DI: 04026575429219 All lot numbers within the labeled expiration date
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1507-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1508-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1509-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1510-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1511-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1512-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1513-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1514-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1515-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1516-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1517-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1518-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1519-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1520-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1521-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1522-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1523-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1524-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1525-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1526-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1527-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1528-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1529-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1530-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1531-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1532-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1533-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1534-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1535-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1536-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1537-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1538-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1539-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1540-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1541-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1542-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1543-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1544-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1545-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1546-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1547-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1548-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1549-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1550-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1551-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1552-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1553-2023 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1554-2023 | Class II | Ongoing | Voluntary: Firm initiated |
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