The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1633-2021·Announced 2021-05-26

BPB medica Kyphoplasty Cannula Recalled for Potential Sterility Failure

BPB medica is recalling 10 units of RENOVA SPINE kyphoplasty cannulas labeled as sterile but potentially not sterilized. The recall covers distribution in Mississippi and Kentucky.

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, FDA Class II recalls with potential for significant injury (such as infection from non-sterile medical devices) are categorized as Severe.

Plain-English summary

BPB medica is recalling 10 units of RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US. The recall was initiated because the products were labeled as sterile but may not have been sterilized.

The affected units, identified by batch number 20061307, were distributed nationwide in the United States, specifically within the states of Mississippi and Kentucky. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and facilities that have received these products should stop using them immediately and contact the recalling firm for instructions on return or disposal. Patients who have received treatment with these devices should consult their healthcare provider if they have concerns regarding the sterility of the equipment.

The recalled product

Product
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
Manufacturer
BIOPSYBELL S.R.L.
Category
Medical Device — Orthopedic / Spinal
Hazard
Affected units
10

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)

  • BATCH: 20061307

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 19 recalled by BIOPSYBELL S.R.L. 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 19 products in this recall →

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