PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING… recallZ-2036-2017 · Smith & Nephew, Inc. · initiated Mar 22, 2017
Class II Terminated All recalls posted in April 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
This lot of left plates were laser etched and packaged as right plates.
FDA root cause category: Mixed-up of materials/components
What the company is doing
Smith & Nephew initiated their recall by email on March 22, 2017. Consignees are being requested to return all affected product in their possession. Distributors were instructed to notify their customers and ensure that the recall instructions were followed. For further questions, please call : 1(800) 821-5700.
Recall details
- Recall number
- Z-2036-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 22, 2017
- Posted by the FDA
- Apr 14, 2017
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 12 units
- Product code
- HRS
- FDA submissions
- K092015
- Distribution
- Internationally to the country of : India
Product description
PERI-LOC VOLAR DISTAL RADIUS - RIGHT 3H STD HEAD LOCKING PLATE, 62 MM LENGTH, SST PLATE, REF 71823114, QTY: (1) NON-STERILE, Rx only, Smith & nephew, Inc., Memphis TN 38116
Code information (models, lots, serial numbers)
Lot 16DM15958
Other devices under the same FDA submission
20 devices cleared under K092015 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Peri-Loc 71800113Smith & Nephew, Inc. · PLATE, FIXATION, BONE5 reports
- Peri-Loc 71800010Smith & Nephew, Inc. · PLATE, FIXATION, BONE3 reports
- Peri-Loc 71800013Smith & Nephew, Inc. · PLATE, FIXATION, BONE3 reports
- Peri-Loc 71800016Smith & Nephew, Inc. · PLATE, FIXATION, BONE2 reports
- Peri-Loc 71800108Smith & Nephew, Inc. · PLATE, FIXATION, BONE2 reports
- Peri-Loc 71801013Smith & Nephew, Inc. · PLATE, FIXATION, BONE2 reports
- Peri-Loc 71801411Smith & Nephew, Inc. · PLATE, FIXATION, BONE2 reports
- Peri-Loc 71821303Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71800019Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71800110Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71800116Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
- Peri-Loc 71800216Smith & Nephew, Inc. · PLATE, FIXATION, BONE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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