Device recall: LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40
Class II FDA enforcement event 92088. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Linkbio Corp. started this device recall on 21 Mar 2023. The firm address in the FDA record is in Rockaway, NJ. FDA put the recall in Class II. FDA event 92088 has 48 product records. The first FDA enforcement report date is 10 May 2023. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico,…
Recalling firm
Linkbio Corp., Rockaway, NJ.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
48 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1507-2023 | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2020/40 | 14 units | Class II | Ongoing | 10 May 2023 |
| Z-1508-2023 | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2020/46 | 18 units | Class II | Ongoing | 10 May 2023 |
| Z-1509-2023 | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2020/52 | 17 units | Class II | Ongoing | 10 May 2023 |
| Z-1510-2023 | LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Item Number: 15-2020/60 | 12 units | Class II | Ongoing | 10 May 2023 |
| Z-1511-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Item Number: 15-2028/01 | 14 units | Class II | Ongoing | 10 May 2023 |
| Z-1512-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Item Number: 15-2028/02 | 13 units | Class II | Ongoing | 10 May 2023 |
| Z-1513-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Item Number: 15-2028/03 | 13 units | Class II | Ongoing | 10 May 2023 |
| Z-1514-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Item Number: 15-2028/04 | 14 units | Class II | Ongoing | 10 May 2023 |
| Z-1515-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Item Number: 15-2028/05 | 19 units | Class II | Ongoing | 10 May 2023 |
| Z-1516-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Item Number: 15-2028/06 | 15 units | Class II | Ongoing | 10 May 2023 |
| Z-1517-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Item Number: 15-2028/07 | 19 units | Class II | Ongoing | 10 May 2023 |
| Z-1518-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Item Number: 15-2028/08 | 24 units | Class II | Ongoing | 10 May 2023 |
| Z-1519-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Item Number: 15-2028/09 | 12 units | Class II | Ongoing | 10 May 2023 |
| Z-1520-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Item Number: 15-2028/10 | 13 units | Class II | Ongoing | 10 May 2023 |
| Z-1521-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11 | 15 units | Class II | Ongoing | 10 May 2023 |
| Z-1522-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Item Number: 15-2028/12 | 14 units | Class II | Ongoing | 10 May 2023 |
| Z-1523-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13 | 18 units | Class II | Ongoing | 10 May 2023 |
| Z-1524-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Item Number: 15-2028/14 | 15 units | Class II | Ongoing | 10 May 2023 |
| Z-1525-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Item Number: 15-2028/15 | 15 units | Class II | Ongoing | 10 May 2023 |
| Z-1526-2023 | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Item Number: 15-2028/16 | 18 units | Class II | Ongoing | 10 May 2023 |
| Z-1527-2023 | LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2030/02 | 17 units | Class II | Ongoing | 10 May 2023 |
| Z-1528-2023 | LINK SLED Knee System: ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2030/03 | 15 units | Class II | Ongoing | 10 May 2023 |
| Z-1529-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04 | 16 units | Class II | Ongoing | 10 May 2023 |
| Z-1530-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2030/06 | 14 units | Class II | Ongoing | 10 May 2023 |
| Z-1531-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2030/07 | 14 units | Class II | Ongoing | 10 May 2023 |
| Z-1532-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2030/08 | 20 units | Class II | Ongoing | 10 May 2023 |
| Z-1533-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2030/10 | 12 units | Class II | Ongoing | 10 May 2023 |
| Z-1534-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2030/11 | 20 units | Class II | Ongoing | 10 May 2023 |
| Z-1535-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2030/12 | 15 units | Class II | Ongoing | 10 May 2023 |
| Z-1536-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2030/13 | 13 units | Class II | Ongoing | 10 May 2023 |
| Z-1537-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2030/14 | 14 units | Class II | Ongoing | 10 May 2023 |
| Z-1538-2023 | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2030/15 | 16 units | Class II | Ongoing | 10 May 2023 |
| Z-1539-2023 | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1540-2023 | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46 | 4 units | Class II | Ongoing | 10 May 2023 |
| Z-1541-2023 | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52 | 7 units | Class II | Ongoing | 10 May 2023 |
| Z-1542-2023 | LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1543-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1544-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1545-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1546-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1547-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM Item Number: 15-2230/07 | 3 units | Class II | Ongoing | 10 May 2023 |
| Z-1548-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1549-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10 | 3 units | Class II | Ongoing | 10 May 2023 |
| Z-1550-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11 | 3 units | Class II | Ongoing | 10 May 2023 |
| Z-1551-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1552-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM Item Number: 15-2230/13 | 5 units | Class II | Ongoing | 10 May 2023 |
| Z-1553-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14 | 8 units | Class II | Ongoing | 10 May 2023 |
| Z-1554-2023 | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15 | 5 units | Class II | Ongoing | 10 May 2023 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 48Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Mar 2026 | LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136. | Device | Class II | 1 |
| 25 Apr 2023 | LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for prim | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-1507-2023The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 92088. https://recallregister.com/fda/ii/92088/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 92088?
- The event has 48 product records. The first record gives this quantity:
14 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.