Allendale, NJ, United States
Stryker Spine recalls
6 recalls recorded since 2018, most recently on 28 February 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)3
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 February 2025
- Reason
- Potential for the gold unlock button to separate from the inserter.
- Distribution
- Domestic: CA, CO, FL, GA, IL, MA, NE, NH, NY, OK, PA, TX, UT. International: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1489-2025, Z-1488-2025, Z-1490-2025, Z-1491-2025
- Monterey AL Implant Inserter; 14/16mm; Catalog 48019120.
- Monterey AL Implant Inserter; 10/12mm; Catalog 48019100.
- Monterey AL Implant Inserter; 18/20mm; Catalog 48019130.
- Monterey AL Implant Inserter; 22mm; Catalog 48019140.
Ongoing Class II Medical devices
- Recall started
- 23 August 2024
- Reason
- Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadvertently removed.
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3210-2024
- AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C
Ongoing Class II Medical devices
- Recall started
- 1 November 2023
- Reason
- Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
- Distribution
- US: MD, MI, NM, TX & OUS: Canada & France.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0610-2024
- LITe Decompression Snake Arm, REF 48080230
Terminated Class II Medical devices
- Recall started
- 18 May 2021
- Terminated
- 15 April 2022
- Reason
- The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2100-2021, Z-2101-2021
- Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN 00808232000962
- Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN 00808232000979
Terminated Class II Medical devices
- Recall started
- 11 March 2021
- Terminated
- 5 January 2023
- Reason
- Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1437-2021
- Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
Terminated Class II Medical devices
- Recall started
- 13 August 2018
- Terminated
- 23 May 2019
- Reason
- The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
- Distribution
- US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0092-2019
- AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.