Synthes Stem Extractor Recalled Due to Potential Screw Breakage
Synthes, Inc. is recalling 31 Stem Extractor f/Guide Bar units because the connection screw may break during use.
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 involves a medical device with a potential mechanical failure (screw breakage) that poses a risk of harm during a surgical procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Synthes, Inc. is recalling 31 units of the Stem Extractor f/Guide Bar, part number 03.401.072. This medical device is instrumentation used for the extraction and revision of Epoca shoulder implants.
The recall was initiated because there is a potential for the connection screw of the stem extractor to break. The affected units were distributed nationwide in the United States, as well as to Canada and Switzerland. The specific lot codes associated with this recall are 09-6793, 10-2637, 10-5070, 12-2707, 14-1085, and 15-8949.
Healthcare providers and facilities should stop using the affected devices and contact Synthes, Inc. for further instructions on the recall process.
The recalled product
- Product
- Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 31
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 (6)
- 09-6793
- 10-2637
- 10-5070
- 12-2707
- 14-1085
- 15-8949
Distribution
Distributed nationwide across the United States.
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