FDA Medical Device Recalls (openFDA)
Smith & Nephew Orthopaedics GmbH: INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
- Recall number
- Z-1133-2022
- Recalling firm
- Smith & Nephew Orthopaedics GmbH
- Product
- INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Left INTERTAN 1.5 NAIL 13mm X 42cm 130DEG. Right
- Status
- Open, Classified
- Initiated
- 2022-04-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- Right nails were anodized, marked, and labelled as left nails and vice versa
- Root cause
- Under Investigation by firm
- Action
- The firm sent out a recall notification letter via email and overnight mail on 04/22/2022. The letter instructs the consignee to check inventory, return affected product, and complete the response form. Distributors were informed to notify their customers of the field action.
- Quantity
- 17 units
- Distribution
- Distributed nationwide to GA, OH, IN, TX, CO, MO, TN, CA, NC, PA and internationally to Canada, Australia.
- Lot, serial or model codes
- Product number: 71676627 (DI: 00885556131633), Batch Number: 21LT56988; 71676628 (DI: 00885556040027), Batch number: 21LT56989
- 510(k) numbers
- ["K040212"]
- PMA numbers
- not on file
- Product code
- JDS
- Firm FEI
- 3002465897
- Firm city
- Tuttlingen
- Firm state
- not on file
- Firm country
- Germany
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