Z-1439-2012

Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. Cortical...

Name: Z-1439-2012 Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. Cortical...
Creator: Biomet, Inc.
Published: 2012-03-15
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-03-15 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. Cortical Locking Screw for securing a Proximal Humeral... on 2012-03-15. The reason FDA records is "Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm". 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-1439-2012
Status: Terminated
Initiated: 2012-03-15
Posted: 2012-04-19
Terminated: 2013-08-29
Recalling firm: Zimmer GmbH
Product: Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: A March 15 2012 Urgent Medical Device Recall Notice was sent to Distributors, Operating Room Managers, and Physicians with directions to locate and remove recalled items with instructions to provide the recall notice to any sub-accounts. The letter also identified the affected product and explained the reason for the recall. OR Managers and Physicians are to confirm recall notice receipt by calling 800-348-9500, extention 3983 or 3009 and make arrangements for product return. Distributors are to complete and FAX back the response tracking form to the attention of Angi Dickson, Biomet @ 574-372-1638. Questions should be directed to 574-372-3983 or 574-371-3009 M- F, 8 AM- 5 PM, (ET).
Quantity in commerce: 45
Distribution: Worldwide Distribution -- USA, including NJ, TX, VA, MI IL, KT, & Puerto Rico, and country of the Netherlands.
Product codes and lots: Item 37728, Lot 989520; Lot 850910 ; Lot 091250 Lot 429270

Product code HRS

K062494Class IIEbi Optilock Upper Extremity Plating SystemEbi, L.P. / cleared 2006-10-19

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)