Pega Medical Inc.
Complete recall history across all FDA and CPSC categories — 9 total recalls
Pega Medical Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (9)
FDA medical device enforcement actions by Pega Medical Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 3, 2020 | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medulla... | The lot number on the pediatric orthopedic implant driver instrument handle d... | Class III |
| Oct 2, 2019 | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm ... | There is a potential for the screws to have become loosened during ultrasonic... | Class II |
| May 29, 2019 | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedu... | Handle could jam with the Driver due to the detachment of an internal Connect... | Class II |
| Oct 20, 2015 | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of th... | SCFE Driver's threaded shaft broke close to the knob when a manual force was ... | Class II |
| Jun 15, 2015 | Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Scr... | SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the h... | Class II |
| Apr 10, 2015 | Female Driver, Part number FDr101, instrument used for the insertion of the F... | The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Te... | Class II |
| Feb 20, 2015 | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog... | Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identifi... | Class II |
| Mar 5, 2014 | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. ... | The outer package label contained the incorrect length of the device. There i... | Class II |
| Feb 7, 2014 | Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid ... | The Male Components in this lot are made of material with lower strength than... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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