FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
- Recall number
- Z-0372-2016
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Smith & Nephew PERI-LOC VOLAR DISTAL RADIUS PLATE STANDARD 3 HOLE SHORT, LEFT - 62 MM, STERILE R, Rx only, REF Numbers: 71863110 Bone fixation plate
- Status
- Terminated
- Initiated
- 2015-10-20
- Posted
- 2015-12-04
- Terminated
- 2016-09-21
- Reason
- The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.
- Root cause
- Employee error
- Action
- Distributors, notified by Fed- Ex on 10/20/2015, were asked to quarantine the product and return it.
- Quantity
- 9 units
- Distribution
- International only Germany, Japan, Russia
- Lot, serial or model codes
- Batch # 14KT47574
- 510(k) numbers
- ["K083032"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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