Z-2601-2010

7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine...

Name: Z-2601-2010 7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine...
Creator: Biomet, Inc.
Published: 2010-07-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-07-01 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of 7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL... on 2010-07-01. The reason FDA records is "The affected instruments are discolored and/or have a sticky residue on the end". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2601-2010
Status: Terminated
Initiated: 2010-07-01
Posted: 2010-09-28
Terminated: 2012-08-20
Recalling firm: Zimmer GmbH
Product: 7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. Usage: Bone Coring Device used in ACL and PCL procedures.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The affected instruments are discolored and/or have a sticky residue on the end.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755.
Quantity in commerce: 35
Distribution: US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
Product codes and lots: 705630.

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)