Agency classClass IIOur severity:High FDA (Devices)·Z-1250-2018·Announced 2018-04-04

Stryker AutoPlex Bone Cement Recalled for Sterility Assurance Issues

Stryker is recalling AutoPlex bone cement systems because bioburden levels were found to be higher than acceptable rates, potentially compromising sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of sterility assurance in a medical device, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling the AutoPlex System and AutoPlex System with VertaPlex HV bone cement products. The recall was initiated because bioburden levels were found to be higher than internal acceptable rates, indicating a lack of sterility assurance.

The affected products include the AutoPlex System (Product Number: 0605-887-000) and the AutoPlex System with VertaPlex HV (Product Number: 0607-687-000). A total of 1,244 units were distributed in all 50 U.S. states, the District of Columbia, and several international countries including Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom.

Specific lot numbers affected include 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, and 17291022. Healthcare providers and facilities should stop using these products and contact Stryker for instructions on return or replacement.

The recalled product

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.
Manufacturer: Stryker Instruments Div. of Stryker Corporation
Category: Medical Device — Orthopedic Implants
Hazard: sterility
infection
Affected units: 1,244

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

1. Lot Number: 17278012
2. Lot Numbers: 17278012
17278022
17279022
17282012
17282022
17291012
17291022 UDI: (01)4546540593108
(01)7613252039259

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 13 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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Same hazard · sterility