FDA Medical Device Recalls (openFDA)
Biorep Technologies: Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
- Recall number
- Z-1538-2014
- Recalling firm
- Biorep Technologies
- Product
- Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
- Status
- Terminated
- Initiated
- 2014-03-19
- Posted
- 2014-05-02
- Terminated
- 2014-08-07
- Reason
- The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
- Root cause
- Nonconforming Material/Component
- Action
- Biorep Technologies sent a letter dated March 19, 2014, to its affected customer. It was advised to due to the high risk, according to our risk categories shown in Table 2, at this time, it is recommended that product be retrieved from its points of use. Any further questions please call (305) 687-8074.
- Quantity
- 80 boxes (480 units)
- Distribution
- US Distribution to a distributor in MN.
- Lot, serial or model codes
- Lot numbers: 166934413 (expires 2016/12/10), and 166903414 (expires 2017/02/03).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWS
- Firm FEI
- 3005593675
- Firm city
- Miami
- Firm state
- FL
- 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