Z-1199-2017Class II

6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates...

Name: Z-1199-2017 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates...
Creator: Acumed LLC
Published: 2017-01-19
License: https://open.fda.gov/license/

Acumed LLC / initiated 2017-01-19 / Terminated / root cause: manufacturing process

FDA source

Acumed LLC began a recall of 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... on 2017-01-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1199-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-19
Posted: 2017-02-14
Terminated: 2017-05-08
Recalling firm: Acumed LLC
Product: 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.
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Mixed-up of materials/components
Action: Acumed sent an Urgent Medical Device Recall letter dated January 16, 2017, to all affected customers on January 19, 2017. Consignees were instructed to follow special instructions and send survey to [email protected]. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email [email protected] to obtain a Return Material Authorization (RMA) number or contact your agent directly. International customers with questions or need to return products to Acumed, please contact Acumed Business Service via email at [email protected] or via phone 877-627-9957, choose Option 4 (US and Canada), or call 001-503-627-9957, choose option 4 (outside of US and Canada) have to obtain a Return Material Authorization (RMA) number.
Quantity in commerce: 15 units
Distribution: Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
Product codes and lots: Lot number: 383813

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1199-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1199-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-22	2017-02-14

Product code HRS

K122538Class IIAcumed Pelvic Bone Plate SystemAcumed, LLC / cleared 2012-11-19

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)