FDA Medical Device Recalls (openFDA)
Acumed LLC: 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 "
- Recall number
- Z-0447-2009
- 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 "
- Status
- Terminated
- Initiated
- 2008-05-13
- Posted
- 2008-12-11
- Terminated
- 2010-05-13
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- ["K992525"]
- PMA numbers
- not on file
- Product code
- HSD
- Firm FEI
- 1000125930
- Firm city
- Hillsboro
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28