Stryker Corporation: ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

Is my product affected?

ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.

• UPC 07613154643264

Check against the official notice below — it lists the full affected range.

What happened

Stryker Corporation is recalling 60,753 units of its ACL Disposable Pack Bone-Tendon-Bone (Model 0234020280), a sterile surgical instrument set used in anterior cruciate ligament reconstruction procedures. Routine bioburden testing found that certain lots had contamination levels exceeding the manufacturer's internal acceptable rates. The affected product was distributed domestically and internationally to Australia and Mexico.

The specific recalled lot is Lot No. 17299AG2 (UDI 07613154643264). The source document does not specify what actions affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.

Details from the source

Reason for recall: Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries. Distribution: Distributed domestically to . Distributed internationally to Australia and Mexico. Quantity: 60,753 units total Lot/code info: Model 0234020280, UDI 07613154643264, Lot No. 17299AG2

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Alaris Syringe Pump, Model 8110. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The2017-11-17
• Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The mod2017-11-17
• StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (2017-11-17
• STRYKER CASSETTE PUMP, AHTO Tube Set, labeled sterile. Includes the following: a. Stryker AHTO Tube Set Packaging (Model 0250070600); b. Stryker AHTO Tube Set with Tip Packaging (Model 0250070620);2017-11-17
• Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left2017-11-16

All FDA (Device enforcement) recalls