Z-0906-2009

Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original...

Name: Z-0906-2009 Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original...
Creator: Biomet Microfixation, Inc.
Published: 2008-05-21
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2008-05-21 / Terminated / root cause: labeling and UDI

FDA source

Biomet Microfixation, Inc. began a recall of Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc... on 2008-05-21. The reason FDA records is "The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0906-2009
Status: Terminated
Initiated: 2008-05-21
Posted: 2015-06-25
Terminated: 2009-09-11
Recalling firm: Biomet Microfixation
Product: Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed domestically. Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek.
Product code: EMG Forceps, Tooth Extractor, Surgical
Reason for recall: The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Customers were contacted by e-mail notification with read receipt. Customers were notified in the e-mail to immediately discontinue use of the recalled product and return the affected items to Biomet Microfixation, Inc. The e-mail also included an Inventory Reconciliation form for customers to complete and return via fax (904-741-1801) to Biomet Microfixation, Inc. For questions related to this notice, please call 1-800-874-7711 or 904-741-4400 extension 448, Monday through Friday, 8 a.m.-4 p.m. Eastern Standard Time (EST).
Quantity in commerce: 4
Distribution: International Distribution including countries of Ireland and Japan.
Product codes and lots: Lot Number 050801.

Product code EMG

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)