FDA Medical Device Recalls (openFDA)
Pega Medical Inc.: Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
- Recall number
- Z-2038-2020
- Recalling firm
- Pega Medical Inc.
- Product
- Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.
- Status
- Terminated
- Initiated
- 2020-04-03
- Posted
- not on file
- Terminated
- 2020-11-20
- Reason
- The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
- Root cause
- Nonconforming Material/Component
- Action
- On 04/03/2020 Pega Medical Inc. sent out an email which included a Field Safety Notice letter to their US consignee identifying the problem, the actions to be taken by the customer/user in order to prevent risks for patients/users, and the actions planned by Pega Medical Inc. to correct the problem. PRODUCTS: The Handle of the Driver of the Simple Locking intramedullary System (SLIM) WITH CATALOG # SLM-HND100 which was distributed to the identified US consignee on 12/24/2019, with lot #8204-1 marked on the part (the driver handle) and with packaging labeled with lot# 8204-01. ACTION TO BE TAKEN BY THE CUSTOMER/USER: "Identify the device with the same catalogue number and lot number "Verify and correct any record on your files that may indicate the lot number of this part. The lot indicated in the records must be 8204-1. "If the part is still in its original package: Place provided label over the previous label making sure that all the information in the previous label is completely hidden. "If the part is not in its original package: No further action is required.
- Quantity
- 3 units
- Distribution
- US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.
- Lot, serial or model codes
- SLIM Handle with Catalog #SLM-HND100 with etched lot code #B204-1 on the handle and with Lot# B204-01 on the packaging label.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3000327445
- Firm city
- Laval
- Firm state
- not on file
- Firm country
- Canada
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