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Terminated

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 Number 30-0098 90.0 mm Tension Band Pin; Part Number 30-0099 50.0 mm Tension Band Kit; Part Number TB-1550K-S 70.0 mm Tension Band Kit; Part Number TB-1570K-S 90.0 mm Tension Band Kit; Part Number TB-1590K-S Product Usage: Acumed Tension Band Pin is intended to be used with orthopedic wire to address malleolar, patella, and olecranon fractures in tension band wiring procedures. This device is not intended for usage in the spine.

FDA Recall Z-1516-2014 · Posted 2014-04-25

Recalling FirmAcumed LLC
Recall StatusTerminated
Product CodeHRS
Date Initiated2014-03-26
Date Terminated2015-02-04
Product Quantity2544 unit in the US and 3584 units outside the US

Reason for Recall

Certain lots of Acumed Tension Band Pins are being recalled because the implantable product was manufactured with a grade of stainless steel that is not within specifications.

Firm Action

Acumed sent an Urgent Medical Device Recall letter dated March 26, 2014 to all affected customers. The letter identified the affected products, problem and actions to be taken. Customers are instructed to immediately stop using and/or distributing all lots identified in the letter. Return affected products as instructed in the letter. For questions contact Acumed Business Service via email at [email protected] or via phone at 877-627-9957.

Root Cause

Component change control

Distribution Pattern

US Nationwide Distribution - in the states of CA, CO, FL, GA, LA, MI, MN, MO, OH, OR, PA, PR, TX, UT, VA, WA and WY. Product was distributed outside the US to: Australia, China, Figi, France, Great Britain, Italy, Japan, Korea, Maylasia, Sweden, South Africa, Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K931244BONE PLATEAcu Med, Inc. · 1994-02-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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