FDA Medical Device Recalls (openFDA)
Nextremity Solutions: Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
- Recall number
- Z-1127-2020
- Recalling firm
- Nextremity Solutions
- Product
- Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.
- Status
- Terminated
- Initiated
- 2019-12-16
- Posted
- not on file
- Terminated
- 2020-09-08
- Reason
- The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.
- Root cause
- Under Investigation by firm
- Action
- On December 16, 2019, the firm notified customers and distributors via recall notification letter and e-mail. The notification instructed return of all product with the specified lot number. If customers have any questions, please call customer service at 574-371-3071 between 8AM-5PM EST, Monday thru Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
- Quantity
- 40
- Distribution
- Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.
- Lot, serial or model codes
- Lot M1502
- 510(k) numbers
- ["K182201"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3009540749
- Firm city
- Warsaw
- Firm state
- IN
- 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