CLASS II Device recall · Reported 22 Feb 2017 · FDA Enforcement Report
6-hole Pubic Symphysis plate (PN 70-0451) recalled by Acumed
Acumed is recalling 6-hole Pubic Symphysis plate (PN 70-0451). The recall was initiated on 19 Jan 2017 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-1199-2017
- FDA event ID
- 76332
- Recalling firm
- Acumed, Hillsboro, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Jan 2017
- FDA classified
- 14 Feb 2017
- Reported
- 22 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 19 Jan 2017 | Recall initiated by company | |
| 14 Feb 2017 | Classified by FDA | +26 days |
| 22 Feb 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
Where it was distributed
Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
Questions about this recall
Is 6-hole Pubic Symphysis plate (PN 70-0451) recalled?
Yes. Acumed recalled 6-hole Pubic Symphysis plate (PN 70-0451) on 19 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1199-2017.
Why was it recalled?
The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed.
Which lots are affected?
Lot number: 383813
Where was it sold?
Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and 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 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.
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