Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.

FDA device recall Z-1523-2015 · posted 2015-04-27 · Terminated

Recall details

Recalling firm

Zimmer Gmbh

Reason for recall

Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.

Action taken

On 3/18/2015, URGENT MEDICAL DEVICE RECALL Notification - LOT SPECIFIC letters were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LXH

Quantity affected

30 units

Distribution

Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.

Date initiated

2015-03-18

Date posted

2015-04-27

Date terminated

2015-09-23

Location

Winterthur, Switzerland