Orthopedic manual Surgical Instrument handle for Simple Locking Intra… — Class III medical device recall Z-2038-2020
Terminated recall by Pega Medical Inc., reported 2020-05-27, distributed nationwide. The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on t
| Recall number | Z-2038-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pega Medical Inc., Laval, N/A, Canada |
| Recall initiated | 2020-04-03 |
| Classified | 2020-05-15 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2020-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | labeling |
| Lot numbers | B204-01, B204-1 |
| Model numbers | SLM-HND100 |
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.
Reason for recall
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2038-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.