Z-1523-2015Class II

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

Name: Z-1523-2015 Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder
Creator: Zimmer Gmbh
Published: 2015-03-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-03-18 / Terminated / root cause: manufacturing process

FDA source

Zimmer Gmbh began a recall of Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder on 2015-03-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1523-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-18
Posted: 2015-04-27
Terminated: 2015-09-23
Recalling firm: Zimmer GmbH
Product: Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 30 units
Distribution: Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
Product codes and lots: Lot Number(s): 13870129 & 13878179.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1523-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1523-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)