Agency classClass IIOur severity:Severe FDA (Devices)·Z-0931-2015·Announced 2015-01-14

Synthes Small Electric Drive Recalled for Unintended Start and Malfunction

Synthes (USA) Products LLC is recalling 12 Small Electric Drive units due to potential unintended starts or reverse mode failures that could cause tissue damage.

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 and the source text explicitly states that injuries may need surgical or medical intervention, which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or potential for serious harm.

Plain-English summary

Synthes (USA) Products LLC is recalling 12 units of the Synthes Small Electric Drive (SED), part number 05.001.175. The device is designed for use in general traumatology, particularly for hand and foot applications involving surgical procedures such as drilling, burring, reaming, and cutting of bone and hard tissue. The recall covers all lots of part number 05.001.175, specifically lot numbers 28, 40, 41, 42, 53, 105, 107, 111, 112, 113, and 115.

The recall is being issued because the device may operate solely in reverse mode, fail to operate in reverse mode when intended, not function, or unintentionally start. The source text notes that an unintended start of the hand piece or operation in the wrong mode or direction could cause bone, soft tissue, peripheral nerve, and/or vascular damage. Injuries resulting from these malfunctions may require surgical or medical intervention. Additionally, surgical delay and postoperative local infection are identified as potential risks.

The affected units were distributed to Florida only. Healthcare providers and facilities that have received these devices should stop using them immediately and contact the recalling firm for instructions on return or replacement.

The recalled product

Product: Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and food applications involving surgical procedures such as drilling, burring, reaming, pin and wire placement, cutting of bone and…
Manufacturer: Synthes (USA) Products LLC
Category: Medical Device — Surgical Power Tools
Hazard: unintended-start
tissue-damage
nerve-damage
vascular-damage
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 (12)

All lots of part number 05.001.175
lot numbers: 28
40
41
42
53
105
107
111
112
113
115.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Synthes (USA) Products LLC

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