Acumed Recalls Tension Band Pins Due to Steel Specification Defect
Acumed LLC is recalling specific lots of Tension Band Pins because they were manufactured with stainless steel that does not meet specifications.
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 an implantable medical device with a material defect (stainless steel not within specifications). Per the rubric, this is classified as a risk-of-harm product where injury has not yet been reported, warranting a score of 3.
Plain-English summary
Acumed LLC is recalling certain lots of Acumed Tension Band Pins. The recall is being conducted because the implantable products were manufactured with a grade of stainless steel that is not within specifications.
The affected products include 50.0 mm, 70.0 mm, and 90.0 mm Tension Band Pins and corresponding Tension Band Kits. These devices are intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. The source text does not specify the number of affected units or the specific dates of distribution.
Consumers and healthcare providers should check their inventory against the specific lot numbers listed in the official recall notice to determine if they possess affected devices. If a device is found to be affected, it should be removed from use and returned to Acumed LLC according to the instructions provided in the recall communication.
The recalled product
- Product
- The Acumed Tension Band Pin is a fixation pin which is .0625" in diameter and is available in lengths between 35mm and 90mm. It is to be used in conjunction with commonly used orthopedic wire. 50.0 mm Tension Band Pin; Part Number 30-0097 70.0 mm Tension Band Pin; Part Num
- Manufacturer
- Acumed LLC
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 (20)
- 50.0 mm Tension Band Pin: Lot 243639 70.0 mm Tension Band Pin: Lots 241127
- 242707
- 243325
- 243948. 90.0 mm Tension Band Pin: Lots 241128. 242708
- 243327
- 243949. 50.0 mm Tension Band Kit: Lots 216769
- 217002
- 217941
- 219145
- 219402
- 222732
- 223007
- 224312
- 229889
- 232575
- 235490
- 237772
- 244800
- 246204
- 247056. 70.0 mm Tension Band Kit: Lots 210290
Distribution
Part of a larger recall action
This product is one of 2 recalled by Acumed LLC 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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