Z-2713-2011

Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet...

Name: Z-2713-2011 Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet...
Creator: Biomet, Inc.
Published: 2011-04-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-04-07 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the... on 2011-04-07. The reason FDA records is "When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the...". 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-2713-2011
Status: Terminated
Initiated: 2011-04-07
Posted: 2011-06-30
Terminated: 2013-04-08
Recalling firm: Zimmer GmbH
Product: Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the inserter from the stem. If the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require inter
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Biomet Orthopedics, sent two "URGENT MEDICAL DEVICE RECALL NOTICE" letters one dated April 7, 2011 and the second letter dated April 12, 2011 which included an additional lot number, to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the noted product; carefully follow the instructions on the enclosed "FAX Back Response Form"; complete and return the Fax Response Form within three (3) business days via fax to 574-372-1683; use priority carrier for their shipment; If the product was further distributed, they MUST notify and give letter to Hospital personnel, and confirm receipt of this notice by calling, 800-348-9500, extension 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.
Quantity in commerce: 469 both products
Distribution: Worldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Australia, Canada, Chile, Columbia, Costa Rica, Italy, Japan, Korea, Netherlands, New Zealand, Spain and Sweden.
Product codes and lots: 064320, 189990, 293840, 299010, 299020, 401800, 401810, 406610, 444560, 444600, 517880, 517960, 525360, 534260, 657870, 723150 and 727030.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)