Trilogy Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or unc

FDA device recall Z-0875-2015 · posted 2014-12-24 · Terminated

Recall details

Recalling firm

Zimmer Manufacturing B.V.

Reason for recall

Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Subsequent investigation found the polar-hole threads to be present but non-conforming to specifications, in that the minor diameter was undersized. Investigation also indicates that the issue is isolated and affects only lot 62714305, which

Action taken

The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" memo dated 12/4/2014 to its customers. The memo described the product, problem and actions to be taken. The customers were instructed to locate all product from the listed lot and quarantine them immediately; carry out a physical count of all affected product in inventory; complete and return the Inventory Return Certification Form via email to: corporatequality.postmarket@zimmer.com on or before 12/12/2014; return the recalled product along with Inventory Return Certification Form on or before 12/12/2014; keep and maintain a copy for your records; and notify Zimmer of any hospitals that you have further distributed the affected product to and complete spreadsheet template provided. After reviewing this notification you have further questions or concerns, call the customer call center at 1-800-348-2759 between 8:00 am and 5:00 pm EST.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LPH

Quantity affected

68 units

Distribution

Worldwide Distribution: US (nationwide) and countries of: France, Germany, Iran, Romania, Serbia, Singapore, Taiwan, and United Kingdom.

Date initiated

2014-12-04

Date posted

2014-12-24

Date terminated

2015-06-18

Location

Mercedita, PR

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