CLASS II Device recall · Reported 7 May 2014 · FDA Enforcement Report
Tension Band Pin is a fixation pin which is .0625" recalled by Acumed
Acumed is recalling Tension Band Pin is a fixation pin which is .0625" in diameter and is available in, distributed nationwide in the US. The recall was initiated on 26 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1516-2014
- FDA event ID
- 67885
- Recalling firm
- Acumed, Hillsboro, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Mar 2014
- FDA classified
- 25 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 26 Mar 2014 | Recall initiated by company | |
| 25 Apr 2014 | Classified by FDA | +30 days |
| 7 May 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide CaliforniaColoradoFloridaGeorgiaLouisianaMichiganMinnesotaMissouriOhioOregonPennsylvaniaPuerto RicoTexasUtahVirginiaWashingtonWyoming
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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, 211349, 214574, 215405, 217004, 218273, 219230, 220978, 221503, 223008, 223477, 224066, 225554, 227193, 229394, 230287, 230952, 231971, 233742, 235502, 237773, 240512, 241185, 243617, 243945, 244801, 246777, 246779, 246938, 247108, 247109, 247493. 90.0 mm Tension Band Kit: Lots 215053, 217005, 218600, 218700, 221465, 222731, 223009, 223756, 225555, 228951, 231573, 236969, 237774, 243620, 244802, 246939, 246990, 247381.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 67885This product is part of a recall event; the main page for the event is The Osteo-Clage System consists of stainless steel recalled by Acumed.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | The Osteo-Clage System consists of stainless steel recalled by Acumed | Acumed | Foreign Material | Nationwide |
More recalls from Acumed
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Hexalob Screw various sizes recalled by Acumed | Acumed | Device Malfunction | Nationwide |
| Device | CLASS II | RibLoc U Plus 90 Instrument Primary Guide Assy, Low Profile recalled | Acumed | Device Malfunction | Nationwide |
| Device | CLASS II | AcuTwist Acutrak Compression Screws recalled by Acumed | Acumed | Other | Nationwide |
| Device | CLASS II | Dual-Trak Clavicle Screws recalled by Acumed | Acumed | Other | Nationwide |
| Device | CLASS II | Cannulated Screw, Short Thread recalled by Acumed | Acumed | Foreign Material | Nationwide |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |