Maxim Knee System 11-146154
Maxim Knee System 11-146154 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K171054 on 28 Jul 2017 (2 earlier submissions) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00880304001459), active as of 23 Oct 2026. 10 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK171054 | Date28 Jul 2017 | StatusActive |
| United States | GUDID listing | Number00880304001459 | Date24 Oct 2015 | StatusListed |
Official records
- AccessGUDID record 00880304001459
- FDA 510(k) database K171054
- FDA 510(k) database K142933
- FDA 510(k) database K915132
Across registries
- FDA 510(k) K171054 decided 28 Jul 2017 Active
- FDA GUDID UDI-DI 00880304001459 listed 24 Oct 2015 Listed
Recalls
-
- Terminated Z-0938-2019
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
-
- Terminated Z-2289-2018
Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
-
- Terminated Z-2177-2018
One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.
-
- Terminated Z-2183-2018
The label master file was errantly set up as a 63/37mm instead of a 63/67mm. There is no 63/37 size offered, and the product is laser marked with the correct size.
-
- Terminated Z-1219-2017
Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
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- Terminated Z-1756-2015
Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
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- Terminated Z-2104-2011
The firm is recalling the product due to the product's packaging being labeled "I-Beam 75mm. Tibial Plate", but the package actually contains the "Interlok 67mm. CR Tibial Plate".
-
- Terminated Z-0706-2008
- Terminated Z-0707-2008
Mislabeled as to size: Package labeled as containing a 67 mm tray actually contains a 75 mm tray and vice versa.
-
- Terminated Z-0255-2008
Mislabeled as to size: the package actaully contained a 71 mm tray.
Timeline
- Recall initiated FDA recalls Z-2104-2011
- Cleared FDA 510(k) K142933
- Recall initiated FDA recalls Z-1756-2015
- Listed FDA GUDID 00880304001459
- Recall initiated FDA recalls Z-1219-2017
- Cleared FDA 510(k) K171054
- Recall initiated FDA recalls Z-2183-2018
- Recall initiated FDA recalls Z-2177-2018
- Recall initiated FDA recalls Z-2289-2018
- Recall initiated FDA recalls Z-0938-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Maxim Knee System
- Generic name
- Tibial insert
- Model / Ref / Catalog
- 11-146154
- Primary DI / UDI-DI
- 00880304001459
- FDA product code
- JWH, MBH, MBV, HRY, OIY
- GMDN term
- Tibial insert
- Device class
- Class II
- Regulation number
- 888.3560, 888.3565, 888.3530
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
Similar devices in this category
Other devices filed under Tibial insert.