The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1249-2018·Announced 2018-04-04

Stryker Spinal Orthopedic PCD Kit Recalled for Sterility Assurance Issues

Stryker is recalling 12 units of a spinal orthopedic PCD kit because bioburden levels exceeded internal acceptable rates, compromising sterility assurance.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in a medical device corresponds to a severity score of 4 (Severe).

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 12 units of the PCD Kit: Long 90, 13g Match-Ground w/ Bevel (Product Number: 0506-485-000, UDI: (01)4546540907035). This medical device is intended for spinal orthopedic use.

The recall was initiated due to a lack of sterility assurance, as bioburden levels were found to be higher than the manufacturer's internal acceptable rates. The affected lot number is 17277012.

The product was distributed in all 50 U.S. States and the District of Columbia, as well as in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom. Healthcare providers and facilities should check their inventory for this specific product and lot number and stop using it if found.

The recalled product

Product
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
12

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 (1)

  • Lot Number: 17277012 UDI: (01)4546540907035

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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