—#162265

Product

1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.

FDA product code: LOD — Bone Cement
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K032945
Affected lot / code info: 1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259

Why it was recalled

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Root cause (FDA determination)

Environmental control

Action the firm took

Letters dated November 16, 2017, were sent to customers. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected lots are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Business Reply Form (BRF). 5. If you have further distributed these products, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 6. Return the completed BRF to Stryker Instruments Post Market Regulatory Compliance via fax (866-521- 2762) or email (erin.bissonnette@stryker.com). 7. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. 8. Report any adverse events associated with the use of these devices to Stryker Instruments 1-800-253-3210, including any infections potentially associated with the use of affected product.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

Timeline

Recall initiated: 2017-11-09
Terminated: 2019-04-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.