Teleflex Medical Recalls Steel Sutures Due to Needle Attachment Strength Defect
Teleflex Medical is recalling 32,271 units of non-absorbable steel sutures because they failed to meet minimum needle attachment strength requirements.
What this means for you
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 risk-of-harm medical device where the defect (insufficient needle attachment strength) poses a potential safety risk, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex Medical is recalling 32,271 units of non-absorbable, steel, monofilament and multifilament sutures. The product is a prescription-only medical device intended for implantation, specifically described as a smooth or threaded metallic bone fixation fastener made of alloys such as cobalt-chromium-molybdenum and stainless steel. The specific product code is X-4981M4 and the lot number is 02J0800451.
The recall was initiated because the products did not meet minimum needle attachment strength requirements. This defect could potentially affect the integrity of the device during surgical use.
The affected products were distributed worldwide, including the United States, Canada, Germany, and Ireland. Healthcare providers and patients should contact Teleflex Medical for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-mol
- Manufacturer
- Teleflex Medical
- Affected units
- 32,271
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 (2)
- Product Code: X-4981M4
- Lot number: 02J0800451
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Teleflex Medical 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.
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