Z-0447-2009

Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S)...

Name: Z-0447-2009 Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S)...
Creator: Acumed LLC
Published: 2008-05-13
License: https://open.fda.gov/license/

Acumed LLC / initiated 2008-05-13 / Terminated / root cause: labeling and UDI

FDA source

Acumed LLC began a recall of Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius... on 2008-05-13. The reason FDA records is "The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated". 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-0447-2009
Status: Terminated
Initiated: 2008-05-13
Posted: 2008-12-11
Terminated: 2010-05-13
Recalling firm: Acumed LLC
Product: Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 "
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Reason for recall: The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm issued a Urgent Notice: Device Recall on 5/13/08. The firm notified consignees of the issue and asked them to return the product to Acumed with the enclosed product recall effectiveness form for customers. For further information contact Acumed customer service at 1-888-627-9957
Quantity in commerce: 20 units
Distribution: World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain.
Product codes and lots: Modular Shoulder Body Assembly, 15mm, Left: Part number: SH-1540L-S ; Work order number/Lot: W51097 (W=work order, ###=sequential number); Expiration date: 2012-06 (Year/Month) Modular Shoulder Body Assembly, 15mm, Right : Part number: SH-1540R-S ; Work order number/Lot: W51098 (W=work order, ###=sequential number); Expiration date: 2012-06 (Year/Month).

Product code HSD

K992525Class IIAcumed Modular Shoulder SystemAcu Med, Inc. / cleared 2000-02-04

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)