# K830196: Corstren Compression Tube & Plate

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 25, 1983 after 64 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0326-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Apr 28, 2017 · Class II · Z-2600-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
- Apr 28, 2017 · Class II · Z-2594-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
- Apr 28, 2017 · Class II · Z-2593-2017: Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
- Jan 11, 2016 · Class II · Z-1128-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jul 22, 2014 · Class II · Z-2550-2014: Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples f
- Oct 11, 2013 · Class II · Z-1003-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag
- Jun 19, 2013 · Class II · Z-2093-2013: Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
- Jun 19, 2013 · Class II · Z-2091-2013: Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
- Jun 19, 2013 · Class II · Z-2092-2013: Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
- Jun 19, 2013 · Class II · Z-2094-2013: Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
- Jun 19, 2013 · Class II · Z-2090-2013: Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.

Source page: https://510kreport.com/device/K830196
Methodology: https://510kreport.com/methodology