The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-2784-2016·Announced 2016-10-05

Anspach Effort Recalls Small Battery Drive Adaptors Due to Burst Risk

The Anspach Effort, Inc. is recalling 1,833 Small Battery Drive adaptors worldwide because they may generate excessive internal pressure and burst.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst."

Plain-English summary

The Anspach Effort, Inc. is recalling 1,833 units of the Adaptor for Small Battery Drive and Small Battery Drive II (catalog numbers 05.001.024 and 05.001.108). These medical devices are designed for use in traumatology and orthopedic surgery to drill, ream, or cut bone. The recall covers all manufactured lots and serial numbers.

The recall was initiated because there is a potential for the adaptors to generate excessive internal pressure, which may cause the products to burst. The devices were distributed worldwide, including in the United States, Canada, and numerous countries across Europe, Asia, Africa, and the Middle East.

Healthcare providers and consumers should stop using these specific adaptors immediately. The Anspach Effort, Inc. is the recalling firm responsible for managing the recall.

The recalled product

Product
Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The…
Manufacturer
The Anspach Effort, Inc.
Category
Medical Device — Surgical Instrument
Hazard

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/Set/Serial: All Manufactured Lots/Serial Numbers.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by The Anspach Effort, Inc. 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 2 products in this recall →

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