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

FDA device recall Z-1199-2017 · posted 2017-02-14 · Terminated

Recall details

Recalling firm

Acumed LLC

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.

Action taken

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 RecallNotification@acumed.net. Domestic customers with questions or need to return products to Acumed, please contact Acumed Agent Inventory via email AgentInventory@acumed.net 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 BusinessServices@acumed.net 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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

HRS

Quantity affected

15 units

Distribution

Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain

Date initiated

2017-01-19

Date posted

2017-02-14

Date terminated

2017-05-08

Location

Hillsboro, OR

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