CLASS II Device recall · Reported 4 Sep 2013 · FDA Enforcement Report
Synthes Va-lcp Two Column Volar Distal Radius Plate recalled
Synthes (USA) Products is recalling Synthes Va-lcp Two Column Volar Distal Radius Plate and Torque limiting attachment, 2Nm, distributed nationwide in the US. The recall was initiated on 31 May 2013 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-2057-2013
- FDA event ID
- 65556
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 May 2013
- FDA classified
- 26 Aug 2013
- Reported
- 4 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 May 2013 | Recall initiated by company | |
| 26 Aug 2013 | Classified by FDA | +87 days |
| 4 Sep 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm
Product as listed by the FDA
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate and Torque limiting attachment, 1.2Nm Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
Where it was distributed
Nationwide Distribution including the states of AK. AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MD, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI SC, SD, TN, TX, UT, VA, VT, WA WI and WV.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Synthes Va-lcp Two Column Volar Distal Radius Plate and Torque limiting attachment, 2Nm recalled?
Yes. Synthes (USA) Products recalled Synthes Va-lcp Two Column Volar Distal Radius Plate and Torque limiting attachment, 2Nm on 31 May 2013. The recall is Class II and its status is Terminated. Recall number Z-2057-2013.
Why was it recalled?
The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Variable Angle LCP (VA-LCP) Two-Column (Standard & Narrow) Volar Distal Radius Plate. The potential exists for the VA locking screw to be driven through the 2.4mm
Which lots are affected?
Part number J8301-F
Where was it sold?
Nationwide Distribution including the states of AK. AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MD, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI SC, SD, TN, TX, UT, VA, VT, WA WI and WV.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Synthes (USA) Products
All 164| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | 4 Volt(tm) Tap Cortex Screw To recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | 4 Volt Tap Locking Screw Tap To recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled | Synthes (USA) Products | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |