FDA Medical Device Recalls (openFDA)
Zimmer Gmbh: Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
- Recall number
- Z-1523-2015
- Recalling firm
- Zimmer Gmbh
- Product
- Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
- Status
- Terminated
- Initiated
- 2015-03-18
- Posted
- 2015-04-27
- Terminated
- 2015-09-23
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 30 units
- Distribution
- Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
- Lot, serial or model codes
- Lot Number(s): 13870129 & 13878179.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3005233524
- Firm city
- Winterthur
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28