Recall Z-1523-2015
Zimmer Gmbh · initiated March 18, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Codes / lots: Lot Number(s): 13870129 & 13878179.
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-1523-2015
- Initiated
- March 18, 2015
- Posted by FDA
- April 27, 2015
- Terminated
- September 23, 2015
- Product code
- LXH – Orthopedic Manual Surgical Instrument
- Quantity
- 30 units
- Distribution
- Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
- Recalling firm
- Zimmer Gmbh, Winterthur